Atlas FDA

1995

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

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RecordFirmDate
POWERR RANGERS SUNGLASSES (K945917)Dollar Land Stores, Inc.1995-01-12
PRO-TECT SAFETY DRESSING (K941790)Pro-Tect Medical Products, Inc.1995-01-12
ALLDRESS MULTI LAYERED WOUND DRESSING (K945206)Scott Health Care1995-01-12
HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS (K921525)Implant Technology, Inc.1995-01-11
BAXTER CA DIALYZER (K926567)Baxter Healthcare Corp1995-01-11
SNORING MICROPHONE, SM1 (K940015)Pro-Tech, Inc.1995-01-11
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) (K945103)Medtronic Vascular1995-01-11
MALA LATEX EXAM GLOVES AND SCAN-SUB (K946154)Lowenkamp Intl., Inc.1995-01-11
AMALGAM CARRIER (K945220)Buffalo Dental Mfg. Co., Inc.1995-01-11
POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) (K945142)Scican1995-01-11
DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE) (K945830)Dumex Medical Surgical Products, Ltd.1995-01-11
ROYALSHIELD NON-STERILE POWDER-FREE (K945031)Shield Gloves Manufacturer (M) Sdn Bhd1995-01-11
TUBING, NONINVASIVE (K945978)Endoscopic Technologies, Inc.1995-01-11
GUARDPORT (K921478)Health Improvement Assoc.1995-01-11
PISTON SYRINGES (K944757)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-01-11
RISTOCETIN COFACTOR ASSAY KIT (K945414)Chrono-Log Corp.1995-01-11
OLYMPUS NASAL AND SINUS ENDOSCOPES (K944072)Olympus America, Inc.1995-01-11
BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM (K925406)Schneider Intl., Ltd.1995-01-11
HEART 1001 (K931020)Aerotel, Ltd.1995-01-11
CAT-600 PENILE PLETHYSMOGRAPH (K936115)Farrall Instruments, Inc.1995-01-10
CAT-400UL PENILE PLETHYSMOGRAPH (K940128)Farrall Instruments, Inc.1995-01-10
PARAMOUNT CEMENTED HIP STEM PROTHESIS (K942537)Depuy, Inc.1995-01-09
RICHARDS TOTAL KNEE SYSTEM (K933958)Smith & Nephew Richards, Inc.1995-01-09
IMAGEN (K943557)Dako Diagnostics , Ltd.1995-01-09
FLEXIFLO TUBE PLACEMENT VERIFIER (K922216)Abbott Laboratories1995-01-09
SILKON TITANIUM CABLE SYSTEM (K942300)American Medical Electronics, Inc.1995-01-09
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE (K942267)Baxter Diagnostics, Inc.1995-01-09
LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 (K941871)Life Support Products, Inc.1995-01-09
MICRODILUTION/LORACARBEF PANELS (K942089)Baxter Diagnostics, Inc.1995-01-09
SUNGLASSES (K944568)Great Field Industries Co., Ltd.1995-01-09
LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 (K941870)Life Support Products, Inc.1995-01-09
PLATO 3300/1300 (K943454)Rosys, Inc.1995-01-09
POWER RANGERS SUNGLASSES (K945823)Avon Products, Inc.1995-01-09
BLACKSTAR(TM) STAR SYSTEM (K945659)Xomed-Treace, Inc.1995-01-09
INSYTE INTRODUCER CATHETER (K942045)Becton Dickinson Vascular Access, Inc.1995-01-09
STRYKER TOTAL PERFORMANCE SYSTEM (K943569)Stryker Corp.1995-01-09
SWIMEX MULTIDEPTH POOL (MODEL 600T) (K935011)Swimex Systems1995-01-09
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK (K946173)ETHICON, Inc.1995-01-09
INTRAUTERINE CATHETER AND INTRODUCER (K932993)Conceptus, Inc.1995-01-06
OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES (K944704)Xintec Corporation1995-01-06
P.F.C. TOTAL HIP SYSTEM (K944132)Johnson & Johnson Professionals, Inc.1995-01-06
HORIZON 9000 WS (K940415)Mennen Medical, Inc.1995-01-06
THE TITANIUM FIXATION SYSTEM (K943071)Biomedics1995-01-06
STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360 (K936273)Baxter Healthcare Corp1995-01-06
THERAPEP (K944900)Dhd Diemolding Healthcare Div.1995-01-06
OPTILITE VI FIBEROPTIC ACCESSORIES (K944965)Xintec Corporation1995-01-06
VETTA LIGHTWEIGHT CYCLING EYEWEAR (K945683)Shaw, Pittman, Potts & Trowbridge1995-01-05
IRMA BLOOD ANALYSIS SYSTEM (K945240)Diametrics Medical, Inc.1995-01-05
ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA (K946002)Origin Medsystems, Inc.1995-01-05
ALGO-2 NEWBORN HEARING SCREENER (K936039)Natus Medical, Inc.1995-01-05
VIBA-BRUSH (K933870)Rovers B.V.1995-01-05
TOP ACOM STATION (K945293)Siemens Medical Solutions USA, Inc.1995-01-05
ELECTRIC VACUM PUMP (K941096)Impact Instrumentation, Inc.1995-01-05
SUNLGASSES, SPORT SUNGLASSES & FISHING GLASSES (K945735)Shu Gie Industrial Co., Ltd.1995-01-05
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE (K934699)Respironics, Inc.1995-01-05
SUNGLASSES (K945817)Walmart Stores1995-01-05
SUNGLASSES (K945819)Walmart Stores1995-01-05
PECTACLE FRAMES AND/OR SUNGLASSES (K945147)Mi MI Progress Co. , Ltd.1995-01-05
BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS (K944858)Baxter Edwards1995-01-05
CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) (K945655)Miles, Inc.1995-01-05
CALCIUM REAGENT (K944258)Olympus America, Inc.1995-01-05
DST-XL (K942837)Sopha Medical Systems, Inc.1995-01-05
SUNGLASSES (K945818)Walmart Stores1995-01-05
BUNNY SUNGLASSES (K945840)Tony (U.S.A.), Inc.1995-01-05
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS (K943380)Siemens Hearing Instruments, Inc.1995-01-05
ANGIOMAT 3000, 6000, CT INJECTOR (K944875)Lievel-Flarsheim Co.1995-01-04
COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT (K945201)Cook, Inc.1995-01-04
PHENOBARBITAL CALIBRATORS (K945316)Diagnostic Reagents, Inc.1995-01-04
FOG FREE (K945732)Tonn Chemical Co., Inc.1995-01-04
A.W.E.L. (K943614)Medi-Flex1995-01-04
SIEMENS QUANTUM 7E11 TRANSRECTAL TRANSDUCER (K930052)Siemens Quantum, Inc.1995-01-04
IDEAS OCCLUDER (K935964)Ideas For Medicine, Inc.1995-01-04
GODAT UTERINE MANIPULATOR INJECTOR (K935023)Ideas For Medicine, Inc.1995-01-04
HYDRADJUST IV UROLOGICAL TABLE (K943581)Mallinckrodt Group, Inc.1995-01-04
IV CATHETER AND OBTURATOR (K941429)Becton Dickinson Vascular Access, Inc.1995-01-04
ECLIPTOMER (K945604)Bisco, Inc.1995-01-03
SILICONE PUNCTAL PLUG (K945906)Oasis Medical, Inc.1995-01-03
ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY (K935186)Electrophysiology Systems, Inc.1995-01-03
LUBRICATING JELLY (K941831)Barre-National, Inc.1995-01-03
CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH (K926139)Bard Access Systems, Inc.1995-01-03
OREX SHOE COVERS (K943034)Thantex Specialties, Inc.1995-01-02
ASEP PLUS SURGICAL DRAPES (K942294)Angelica Uniform1995-01-02
PATIENT EXAINATION GLOVES (K945045)Phoenix Medical Technology, Inc.1995-01-02
PATIENT EXAMINATION GLOVE (K933602)Kerala Rubber & Reclaims, Ltd.1995-01-02
MECHANICAL WHEELCHAIR - BOING (K945534)Colours 'N Motion1995-01-02
POWDERFREE LATEX EXAMINATION GLOVE (K945247)Sri Johani Sdn. Bhd.1995-01-02
MECHANICAL WHEELCHAIR - SUPERNOVA (K945533)Colours 'N Motion1995-01-02
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Every clearance here is in the API, with alerts when new ones post.