Atlas FDA

2014

3,202 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE (K133963)Adhezion Biomedical, LLC2014-09-09
FUJIFILM ENDOSCOPIC CO2 REGULATOR (K133976)Fujifilm Medical System U.S.A., Inc.2014-09-09
ZEISS CATARACT SUITE MARKERLESS (K141068)Carl Zeiss Meditec, AG2014-09-09
ECARE COORDINATOR (ECC) (K141706)Visicu, Inc.2014-09-09
HD BLOOD PRESSURE MONITOR (K141924)Biocare Asia Corporation , Ltd.2014-09-08
ARENA-C (K141337)Spinefrontier, Inc.2014-09-08
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM (K133584)Eoshealth, Inc.2014-09-08
XIDF-AWS801, ANGIO WORKSTATION, V5.31 (K141541)Toshibamedical Systems Corporation2014-09-08
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) (K141551)Stryker Corporate2014-09-08
RANGE/MESA/DENALI SPINAL SYSTEM (K141873)K2m, Inc.2014-09-08
DEKA SMARTXIDE LASER SYSTEM (K133895)El.En S.P.A.2014-09-05
ARTIS ZEE/ZEEGO SW VC21 (K141574)Siemens Medical Solutions USA, Inc.2014-09-05
ELI 380 ELECTROCARDIOGRAPH (K142105)Mortara Instrument, Inc.2014-09-05
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM (K142035)Arkray Factory, Inc.2014-09-05
AXXENT CERVICAL APPLICATOR (K141343)Icad, Inc.2014-09-05
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM (K140911)Beckman Coulter, Inc.2014-09-05
MSN-006 (K141562)GC America, Inc.2014-09-05
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING (K141248)Varian Medical Systems, Inc.2014-09-05
TRUSCULPT (K133739)Cutera, Inc.2014-09-05
ELECSYS ESTRADIOL III CALCHECK 5 (K142127)Roche Diagnostics2014-09-05
MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP (K141824)Medtronic Sofamor Danek, Inc.2014-09-05
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS (K141552)Care Fusion2014-09-05
LONGFIAN OXYGEN CONCENTRATOR (K131968)Longfian Scitech Co., Ltd.2014-09-05
NEPHROCHECK TEST SYSTEM (DEN130031)Astute Medical, Inc.2014-09-05
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT (K134025)Toshibamedical Systems Corporation2014-09-05
AJAX DENTAL UNIT (K132245)Pro Dental Services, LLC2014-09-05
TRUE BEAM, TRUE BEAM STX, EDGE (K140528)Varian Medical Systems, Inc.2014-09-05
PALACOS R+G PRO (K142157)Heraeus Medical GmbH2014-09-05
MOSAIQ ONCOLOGY INFORMATION SYSTEM (K141572)Impac Medical Systems, Inc.2014-09-05
SURESUBTRACTION LUNG (K133324)Toshiba Medical Systems Corporation, Japan2014-09-05
SOPIX INSIDE, SOPIX2 INSIDE (K140013)Sopro - Acteon Group2014-09-05
FORTICORE (K140280)Nanovis, LLC2014-09-05
COMPAT ENTERAL DELIVERY PUMP SETS (K140947)Nestle Healthcare Nutrition, Inc.2014-09-04
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR (K141272)Minimmally Invasive Devices2014-09-04
IVAS 8 GAUGE BONE BIOPSY KIT (K141673)Stryker Corporation2014-09-04
BIOMET GRAFT DELIVERY SYRINGES (K140710)Biomet Spine (Aka Ebi, LLC)2014-09-04
HFD100 ROCKER ARM ACCESSORY (K141950)Imris, Inc.2014-09-04
BIOGEL PL MICRO SURGICAL GLOVE (K141719)Molnlycke Health Care Us, LLC2014-09-04
RHINIX NASAL FILTER (K134003)Rhinix Aps2014-09-04
CALCULASE II (K140964)KARL STORZ Endoscopy-America, Inc.2014-09-04
HYDRAVIEW GUIDEWIRE (K141831)Brivant Limited2014-09-04
QMASTER-H/REVO (K133797)Telesystems Co., Ltd.2014-09-04
PREMIUM (K133889)Cousin Biotech Sas2014-09-04
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER (K141495)Edwards Lifesciences, LLC2014-09-03
PHOT-X IIS MODEL 505 (K141293)Takara Belmont Corporation2014-09-03
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE (K141590)Eco Medi Glove Sdn. Bhd.2014-09-03
XENCO MEDICAL CERVICAL INTERBODY SYSTEM (K140786)Xenco Medical, LLC2014-09-03
ARTHREX IBALANCE TKA SYSTEM (K141635)Arthrex, Inc.2014-09-03
SYNAPSE 3D TENSOR ANALYSIS (K141514)Fujifilm Meidcal Systems U.S.A.,Inc.2014-09-03
GENERAL SPINAL SYSTEM (K134011)Changzhou Dean Medical Instrument Co, Ltd.2014-09-03
INFRARED HEATING DEVICE (K140865)Pro Medical Supplies, Inc.2014-09-03
VERICORE ZIRCONIA BLANKS (K140877)Whip Mix Corp.2014-09-03
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K140418)Wrp Rubber Products Sdn Bhd2014-09-03
STA LIATEST D-DI (K141144)Diagnostica Stago2014-09-03
VOLUMETRIC INCENTIVE SPIROMETER (K141355)Besmed Health Business Corporation2014-09-03
VITALOGRAPH MODEL 7000 SPIROTRAC (K141546)Vitalograph (Ireland) , Ltd.2014-09-03
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH (K141840)Zimmer, Inc.2014-09-03
ALERE PBP2A SA/CONS CULTURE COLONY TEST (K133851)Alere Scarborough, Inc.2014-09-03
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM (K133911)Genesys Spine2014-09-03
VDRIVE WITH V-LOOP/ VDRIVE DUO (K140804)Stereotaxis, Inc.2014-09-03
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) (K141078)Orthofix Srl2014-09-02
RENOVIS CEMENTED HIP SYSTEM (K141370)Renovis Surgical Technologies, Inc.2014-09-02
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF (K140874)Shanghai Goahui Rubber and Plastic Company2014-09-02
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER (K140690)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2014-09-02
SELEC-3 I.V.ADMINISTRATION SET (K142097)Biomedix, Inc.2014-08-29
EIA SMDP IMMUNOASSAY (K132631)Phadia US, Inc.2014-08-29
HEARTWAY POWER MOBILITY SCOOTER (K132855)Heartway Medical Products Co., Ltd.2014-08-29
IOGYN SYSTEM (K141848)Iogyn, Inc.2014-08-29
CIVA SHEET PD-103 (K140490)Civatech Oncology, Inc.2014-08-29
QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT (K140342)Mindways Software, Inc.2014-08-29
DICOMPACS DX-R WITH FLAT PANEL (K141440)Oehm Und Rehbein GmbH2014-08-29
CLIMB MAMMOGRAPHY VIEWER SOFTWARE (K141364)Climb Medical Systems, Inc.2014-08-29
MEMO 3D ReChord (K142221)Sorin Group Italia S.R.L.2014-08-29
INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (K132943)Synaptic Medical Limited2014-08-29
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS (K140735)Microport Orthopedics, Inc.2014-08-29
ACCU-CHEK Performa Blood Glucose Monitoring System (K133741)Roche Diagnostics2014-08-29
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM (K141796)Synthes (USA) Products, LLC2014-08-29
SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM (K140009)Alma Lasers , Ltd.2014-08-29
DISTAL ELBOW PLATING SYSTEM (K140892)Skeletal Dynamics, LLC2014-08-28
JWX-2 (K140204)Yamaha Motor Co., Ltd.2014-08-28
SILVERLON ISLAND WOUND DRESSING (K141573)Argentum Medical2014-08-28
TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES (K142166)Zimmer, Inc.2014-08-28
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION (K142135)Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic2014-08-28
EASYSTIM TN28_OTC (K140168)Easymed Instruments Co., Ltd.2014-08-28
NIO -INTRAOSSEOUS DEVICE (K142086)Waismed, Ltd.2014-08-28
INFRONT LUMBAR INTERBODY FUSION SYSTEM (K141443)Infront Medical, LLC2014-08-28
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET (K141821)Exactech, Inc.2014-08-28
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED (K142080)Ecolab, Inc.2014-08-28
FINGERTIP PULSE OXIMETER (K140582)Shenzhen Jumper Medical Equipment Co., Ltd.2014-08-28
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP (K142120)AtriCure, Inc.2014-08-28
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM (K141762)Biomet, Inc.2014-08-27
JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 (K133023)Medrad, Inc.2014-08-27
CIANNA MEDICAL SGS SYSTEM (K141318)Cianna Medical, Inc.2014-08-27
STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K133549)Steritec Products Mfg Co, Inc.2014-08-27
MONICA NOVII WIRELESS PATCH SYSTEM (K140862)Monica Healthcare, Ltd.2014-08-27
LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES (K141239)Zibo Litong Plastic Products Co., Ltd.2014-08-27
OPAL CHIRO, 20/20 P-DR (K141435)2020 Imaging2014-08-27
DOSELAB PRO (K141230)Mobius Medical Systems, LP2014-08-27
MINNCARE HD (K133724)Medivators, Inc.2014-08-27
AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K141307)Shijiazhuang Aok Plastic Co., Ltd.2014-08-27
← Previous Next →

Track 2014 automatically

Every clearance here is in the API, with alerts when new ones post.