Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DISPOSABLE POWDER FREE VINYL SYNTHETIC GLOVES (K955091)Safehealth Medical Supply Corp.1995-12-15
ELECTRONIC FLOW METER (K943678)Vitalograph, Inc.1995-12-14
STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE (K954340)Storz1995-12-14
MASTERSCREEN IOS (K954140)Erich Jaeger GmbH & Co. KG1995-12-14
HANYANG SUNGLASSES (K955127)Hanyang Industries, Inc.1995-12-14
OLYMPIC SMART SCALE (K954846)Olympic Medical Corp.1995-12-14
ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA (K953826)Pyramid Biological Corp.1995-12-14
OLYMPIC SMART SCALE (K955177)Olympic Medical Corp.1995-12-14
SPYROCOLLOID WOUND DRESSING (K955383)Polymedica Industries, Inc.1995-12-13
RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) (K952766)Creative Medical Designs, Inc.1995-12-13
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION) (K953731)Abbott Laboratories1995-12-13
ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY (K954300)Sherwood Medical Co.1995-12-13
VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE (K952645)Vital Signs, Inc.1995-12-13
CARBAMAZEPINE EIA TEST (K955100)Diagnostic Reagents, Inc.1995-12-13
AELITEFLO (K955292)Bisco, Inc.1995-12-13
VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE (K953120)Vital Signs, Inc.1995-12-13
ANTI-EM/GP STOCKINGS (K955138)Jobst Institute, Inc.1995-12-13
CIBA CORNING ACS ESTRADIOL-6 ASSAY (K954697)Ciba Corning Diagnostics Corp.1995-12-13
APR ACETABULAR INSERTS IOI BIPOLAR (K935585)Intermedics Orthopedics1995-12-13
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 (K954809)Medtronic Vascular1995-12-13
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM (K954630)Depuy, Inc.1995-12-13
CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM (K955042)Shared Systems, Inc.1995-12-13
ALTA TIBIAL/HUMERAL ROD (K954554)Howmedica Corp.1995-12-13
DEROYAL SURGICAL INSTRUMENT DRAPE (K950565)Deroyal Industries, Inc.1995-12-13
ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT (K955089)Wallace A. Erickson & Co.1995-12-13
EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS (K955001)Everest Medical Corp.1995-12-13
QUIX RAPID PREGNANCY STRIP TEST (K954993)Guardian Scientific, Corp.1995-12-13
SPINAL PEDICLE SCREW, FIXATION, APPLIANCE (K952298)J.B.S., S.A.1995-12-13
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL (K954799)Roche Diagnostic Systems, Inc.1995-12-13
THE NINER NITINOL GUIDEWIRE (K952860)Microvena Corp.1995-12-13
DISPOSABLE ECG MONITORING ELECTRODE (K950473)Nikomed U.S.A., Inc.1995-12-12
AP-18 (K953642)Jeneric/Pentron, Inc.1995-12-12
AMOXICILLIN/CLAVULANIC ACID 2/1 (K954319)Ab Biodisk1995-12-12
URINARY GEL DRAINAGE SYSTEM (K952780)P.A.M., Inc.1995-12-12
HUMAC SYSTEM (K952090)Computer Sports Medicine, Inc.1995-12-11
DAR-2400-15B/30B (K955395)Shimadzu Medical Systems1995-12-11
BIONIKE A/Q PREGNANCY TEST (K954901)Bionike Laboratories, Inc.1995-12-11
ACETAL DENTAL/PREFORMED CLASP (K954971)B & H Technical Services , Ltd.1995-12-11
ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM (K944612)Codman & Shurtleff, Inc.1995-12-11
MASSAGER THERAPUTIC, ELECTRIC (K954203)Cisco Sales Corp.1995-12-11
SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES (K952155)Wembley Rubber Products (M) Sdn Bhd1995-12-11
JANUS I (K952551)3D Ultrasound, Inc.1995-12-11
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (K951494)Emd Chemicals, Inc.1995-12-11
ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES (K954533)Eci Medical Technologies, Inc.1995-12-11
OPTIBOND; OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK (K955070)Optimal Dental (Usa)1995-12-11
ACS PHENOBARBITAL (K953021)Ciba Corning Diagnostics Corp.1995-12-11
MODEL D-285N ADMINISTRATION SET (K954841)Patient Solutions, Inc.1995-12-11
NT SERIES DIGITAL IMAGE MANAGER (K955232)Camtronics, Ltd.1995-12-11
BLOODBORNE PATHOGEN KIT (K953102)Certified Safety Mfg., Inc.1995-12-11
HDL PRECIPITATING REAGENT (K954179)Schiapparelli Biosystems, Inc.1995-12-11
HAMEX TWO (K951028)Northern Orthopaedic Products, Inc.1995-12-11
POWDER FREE LATEX EXAMINATION GLOVES (K954365)Perusahaan Getah Asas Sdn. Bhd.1995-12-11
SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES (K954381)Shanghai Poseidon Plastic Products Co., Ltd.1995-12-11
DEGUBOND X-LITE PLUS (K955118)Degussa Corp.1995-12-11
OPTIBOND 2A PRECOAT (K955068)Sybron Dental Specialties, Inc.1995-12-11
METRO 55G TORIC & SPHERICAL (K953199)Metrosoft, Inc.1995-12-11
A-B ACETABULAR COMPONENT (K954417)Biomet, Inc.1995-12-11
OCTOSTIM (K951682)Freiler1995-12-11
CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT (K955154)Alko Diagnostic Corp.1995-12-11
ELASTYREN HYPOALLERGENIC SURGICAL GLOVES (K954535)Eci Medical Technologies, Inc.1995-12-11
VERSA-VU (K951898)CooperSurgical, Inc.1995-12-11
PROSTYLE INTRA (K955429)Planmeca Oy1995-12-11
ACETAL DENTAL/PREFORMED CLASP (K955946)Pressing DI Monticelli Rag. Stefano1995-12-11
BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES (K946249)C.R. Bard, Inc.1995-12-11
U.S. IOL PHACO HANDPIECE (K954239)U.S. Iol, Inc.1995-12-08
CANNULOC THREADED CANNULA (K955273)Linvatec Corp.1995-12-08
LCX CHLAMYDIA TRACHOMATIS ASSAY (K934622)Abbott Laboratories1995-12-08
CIRCUIT TREE PHACO HANDPIECE (K954237)Circuit Tree1995-12-08
MUSTANG (K954376)Temco, Inc.1995-12-08
WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE (K954754)Unomedical Sdn Bhd1995-12-08
MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP (K953516)Yoav Gershoni1995-12-08
VIDEO ENHANCEMENT UNIT (K954222)Perkins Mfg. Co.1995-12-08
SILICONE ENDOTRACHEAL TUBE (K954751)Unomedical Sdn Bhd1995-12-08
PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE (K954750)Unomedical Sdn Bhd1995-12-08
E-Z BREATHERS (K953042)E-Z Kare Good Health Systems, Inc.1995-12-08
AQUAFLO BTP HYDROGEL WOUND DRESSING (K952938)Sherwood Medical Co.1995-12-08
KOH MICRO-SUTURING INSTRUMENTS (K955479)KARL STORZ Endoscopy-America, Inc.1995-12-08
OLYMPIC WARM-BASSINET (K954216)Olympic Medical Corp.1995-12-08
VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM (K955346)Valley Forge Scientific Corp.1995-12-08
RACE CAR TYMPANOMETER (K955289)American Electromedics Corp.1995-12-08
SUPER SCREW 3.5 MM (K954330)Osteomed Corp.1995-12-08
SPECULITE (K953364)Trylon Corp.1995-12-08
SURGIMOTOR (K954470)W.O.M. World of Medicine GmbH1995-12-08
INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER (K952237)Innovasive Devices, Inc.1995-12-08
PEDIATRIC SILICONE ENDOTRACHEAL TUBE (K954753)Unomedical Sdn Bhd1995-12-08
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION (K954579)Telex Communications, Inc.1995-12-08
SURGIN GENISIS HANDPIECE (K954238)Surgin Surgical Instrumentation, Inc.1995-12-08
ALRECO 40400 (K951926)Allan Rehnstrom AB1995-12-08
GO UNIVERSALK-WIRE FLUTED DRILL (K954543)Genesis Orthopedics, Inc.1995-12-08
COAGULATING CANNULA DEVICE (K953696)Dorsal Orthopedic Corp.1995-12-08
CHROM Z-PLASMINOGEN, CAT. NO. 5244 (K952669)Helena Laboratories1995-12-07
ACS TOURGIDE GUIDING CATHETER (K953987)Advanced Cardiovascular Systems, Inc.1995-12-07
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) (K954582)C.R. Bard, Inc.1995-12-07
UTK-DTE AUTILARY SHIELD (K954146)Mallinckrodt Medical1995-12-06
MAYFIELD CHILD DISPOSABLE SKULL PIN (K941558)Ohio Medical Instrument Co., Inc.1995-12-06
CAP-AID (K954959)Nebl, Inc.1995-12-06
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE (K952688)Empi1995-12-06
FACEPLATE (HEARING AID KIT) (K954236)Truetone Hearing Systems, Inc.1995-12-06
TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (K954912)Trebay Medical Corp.1995-12-06
BRAY RONGEUR (K954699)Johnson & Johnson Professionals, Inc.1995-12-06
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Track 1995 automatically

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