Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) (K935014)Diagnostic Systems Laboratories, Inc.1994-05-09
SUNGLASSES (K941680)Walmart Stores1994-05-09
ISOFLUX IXP FLOW REGULATOR (K925731)Ferguson Medical1994-05-09
EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER (K926560)Fischer Imaging Corp.1994-05-09
PAFLUFOCON A, B, C & D (K940277)Paragon Vision Sciences1994-05-09
SELECT(R) SHOULDER ALL-POLY GLENOID (K931114)Intermedics Orthopedics1994-05-09
ISOFLUX IXL FLOW REGULATOR (K925733)Ferguson Medical1994-05-09
COMFIT (K935464)Wembley Rubber Products (M) Sdn Bhd1994-05-09
CON-KIT (K941129)Medical Chemical Corp.1994-05-09
POWDER FREE LATEX EXMINATION GLOVES (K941754)Sj Medical Products (M) Sdn Bhd1994-05-09
I CARE (K941442)I Care Intl., Inc.1994-05-09
PRIMUS PSS SERIES STERILIZERS (K926185)Primus Sterilizer Co., Inc.1994-05-09
FITIPALDI DRIVING SUNGLASSES (K941415)L'Equipe Visual, Inc.1994-05-09
KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS (K940049)Baxter Healthcare Corp1994-05-06
MODEL 747 AND 747-30 EXAM/TREATMENT TABLE (K941720)Tri W-G, Inc.1994-05-06
KTI HY-Q(TM) WOUND DRESSING (K940738)Kingston Technologies, Inc.1994-05-06
HEMOLAB HEPARICHROM ASSAY (K934274)Biomerieux Vitek, Inc.1994-05-06
BASIC SHOULDER CPM (K931128)Danninger Medical Technology, Inc.1994-05-06
ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM (K940481)Acufex Microsurgical, Inc.1994-05-06
QUADTRAX (K935201)Body Bike, Inc.1994-05-06
E-Z PEG (K921680)Mill-Rose Laboratory1994-05-06
SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH (K940545)Scimed Life Systems, Inc.1994-05-06
CAT SCOOTER (K941966)Genus Medical, Inc.1994-05-06
TROCAR AND CANNULA (K941250)Debusk Technology Corp.1994-05-06
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS (K940581)Respironics, Inc.1994-05-06
REFLECTION ACETABULAR COMPONENT (K932755)Smith & Nephew Richards, Inc.1994-05-06
STRYKER 5050 STRECHAIR (K941738)Stryker Medical1994-05-06
OCCUPATIONAL THERAPY TABLES (K941281)Med Mart, Inc.1994-05-06
UPPER BODY EXERCISER (K926279)Henley Intl.1994-05-05
SIDEKICK II (K931231)Pride Health Care, Inc.1994-05-05
MONOPOLAR SURGICAL INSTRUMENTS (K940552)Tnco, Inc.1994-05-05
EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (K935590)Ep Medical, Inc.1994-05-05
ABDOMINAL / THORACIC PATIENT DRAPE (K930815)Custom Medical Products, Ltd.1994-05-05
41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15 (K940514)Medical Advances, Inc.1994-05-05
STAIR CLIMBER (K926278)Henley Intl.1994-05-05
JO-1 EIA TEST KIT (K935417)David A. Fuccillo, Ph.D.1994-05-05
TYMPOVENT (K936275)Atos Medical AB1994-05-05
OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (K935531)Puritas Health Care, Inc.1994-05-05
LA EIA TEST KIT (K935419)David A. Fuccillo, Ph.D.1994-05-05
CATH-FINDER (K931073)Pharmacia Deltec, Inc.1994-05-05
SURGICAL DRAPE (K931418)Custom Medical Products, Ltd.1994-05-05
EPTFE SHEET COVERING FOR OCULAR IMPLANT (K934834)Oculo Plastik, Inc.1994-05-05
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (K935809)Light Diagnostics1994-05-05
SURGICAL TROCARS (K933458)Ximed Medical Systems1994-05-05
CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS (K934916)Conmedcorp1994-05-05
CONTROL-A-FLO(TM) REGULATOR (K940867)Baxter Healthcare Corp1994-05-05
STRYKER OPERATING ROOM TABLE (K940068)Stryker Medical1994-05-05
CO-CR ANSWER FEMORAL COMPONENT (K931194)Biomet, Inc.1994-05-05
HEAD SHEET (K931455)Custom Medical Products, Ltd.1994-05-05
GEL CUSHION (K941858)Hollister, Inc.1994-05-05
SCL-70 EIA TEST KIT (K935418)David A. Fuccillo, Ph.D.1994-05-05
ALGINATE FIBER TOPICAL WOUND DRESSING (K940404)Adri1994-05-04
CARRASYN ORAL WOUND DRESSING (K933741)Carrington Laboratories, Inc.1994-05-04
COE-SOFT LC (K940565)GC America, Inc.1994-05-04
BELTON MERIT (HEARING AID) (K941395)Beltone Electronics Corp.1994-05-04
RIONET HEARING AID HB-37T (K941140)Authorized Hearing Systems, Inc.1994-05-04
MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE (K934011)Neward Enterprises, Inc.1994-05-04
155 PP AGC-I (K940608)Danavox, Inc.1994-05-04
WHITE RIVER MANUAL BREAST PUMP (K925738)White River (Tm)1994-05-04
T-PLATE (K931692)Onyx Medical Corp.1994-05-04
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON (K933205)Danek Medical, Inc.1994-05-04
CANNULATED CANCELLOUS SCREW (K931680)Onyx Medical Corp.1994-05-04
520 DISPLAY DRIVER- STATUS I (K926298)Vidco, Inc.1994-05-04
MINI PAK (K941636)Starkey Laboratories, Inc.1994-05-04
MIRACLE-EAR WITH POWER CIRCUIT OPTION (K935962)Miracle-Ear, Inc.1994-05-04
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III (K940824)W. L. Gore & Associates, Inc.1994-05-04
RIONET HEARING AID HB-54 (K941021)Authorized Hearing Systems, Inc.1994-05-04
STARKEY EUROLINE A SERIES (K940978)Starkey Laboratories, Inc.1994-05-04
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER (K940521)Mill-Rose Laboratory1994-05-04
SYSTEM, X-RAY, MAMOGRAPHIC (K936161)Technowipe1994-05-04
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT (K932202)Medtronic Vascular1994-05-04
AMG MED BRAND CLINICAL GLASS THERMOMETER (K940380)Amg Medical, Inc.1994-05-04
3M TEGASORB HYDROCOLLOID DRESSING (K940624)3M Company1994-05-04
LEEP AND LLETZ ELECTRODES (K930132)Nordex Medical Corp.1994-05-04
MINI FRAGMENT PLATE (K934614)Onyx Medical Corp.1994-05-04
INTRA S, INTRA SH (K941635)Starkey Laboratories, Inc.1994-05-04
AMSET(TM) CANNULATED BONE SCREW (K931538)Advanced Med/Surg, Inc.1994-05-04
MEDTRONIC GCIII CORONARY GUIDING CATHETER (K935738)Medtronics Interventional Vascular1994-05-04
OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) (K940508)G.W.B. Intl., Ltd.1994-05-04
ANTITHROMBIN III CHROMOGENIC ASSAY (K936196)Baxter Diagnostics, Inc.1994-05-04
AMG MED BRAND CLINICAL GLASS THERMOMETER (K940394)Technolab Industries (Canada) , Ltd.1994-05-04
BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING (K941019)Brady Medical Products Co.1994-05-04
WIDEX S-21 (K941508)Widex Hearing Aid Co., Inc.1994-05-04
FLEXIBLE GRASPING FORCEPS (K941161)Surgical Technologies, Inc.1994-05-04
EPIPHYSIS PLATE (K931684)Onyx Medical Corp.1994-05-04
AME(R) UNIVERSIAL CABLE SYSTEM (K932687)American Medical Electronics, Inc.1994-05-03
IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS (K932923)Implex Corp.1994-05-03
VENSHIELD (K941813)Cybermedic, Inc.1994-05-03
TECNOL PCM 2000 (K932834)Tecnol Medical Products, Inc.1994-05-03
MEDNEXT BUR (K935861)Mednext, Inc.1994-05-03
METHAQUALONE ENZYME IMMUNOASSAY (K940123)Diagnostic Reagents, Inc.1994-05-03
ACS POWERBASE(TM) CORONARY GUIDING CATHETER (K940559)Advanced Cardiovascular Systems, Inc.1994-05-03
ACE CLINICAL CHEMISTRY SYSTEM (K940267)Schiapparelli Biosystems, Inc.1994-05-03
SYNERMED AMYLASE REAGENT KIT (K941091)Synermed, Inc.1994-05-03
PENT CORE PLUS (PASTE-PASTE) (K941373)Jeneric/Pentron, Inc.1994-05-03
FOUNDATION ALL POLY CUP (K934169)Encore Orthopedics, Inc.1994-05-03
LIQUID ALT(SGPT) REAGENT SET (K941287)Pointe Scientific, Inc.,1994-05-03
PS MEDICAL CATHETER PLACEMENT KIT (K940096)Pudenz-Schulte Medical Research Corp.1994-05-03
FLOW DIRECTED THERMODILUTION BALLOON CATHETER (K935404)J-Lloyd Medical, Inc.1994-05-03
DIAGNOSTIC ULTRASOUND SYSTEM (K915403)Hitachi Medical Systems America, Inc.1994-05-03
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Every clearance here is in the API, with alerts when new ones post.