Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PRELOADED SOFT TISSUE ANCHOR (K953954)Linvatec Corp.1996-02-20
REVERSE OSMOSIS SYSTEM (K944493)G.E.M. Water Systems1996-02-20
CONSENSUS ZIRCONIA FEMORAL HEAD (K955386)U.S. Medical Products, Inc.1996-02-20
PRIME CEMENTED CALCAR FEMORAL STEMS (K955620)Orthopaedic Innovations, Inc.1996-02-20
MEDLITE LASER SYSTEM (K955131)Continuum Biomedical, Inc.1996-02-20
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP (K950342)Becton Dickinson Immunocytometry Systems1996-02-20
INTRAN PLUS (K955443)Utah Medical Products, Inc.1996-02-20
MULTICHECK (K952725)Radiometer America, Inc.1996-02-20
OXYPULSE EOC I, EOC II & EOC R (K955129)Eagle Medical Equipment Co.1996-02-16
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM (K955350)Biomet, Inc.1996-02-16
JAMES KOREA OPTICAL FRAMES & SUNGLASSES (K960289)James Korea Co., Ltd.1996-02-16
INDIGO MEDICAL MODEL IDL 830E (K955758)Indigo Medical, Inc.1996-02-16
WAKO AUTOKIT CRP NEW (K955156)Wako Chemicals USA, Inc.1996-02-16
A549 CELL CULTURE (K955921)Viratest Intl., Inc.1996-02-16
TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (K942389)Hogan & Hartson1996-02-16
BACTEC PEDS PLUS/F CULTURE VIALS (K954927)Becton Dickinson Diagnostic Instrument Systems1996-02-16
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM (K955644)Beckman Instruments, Inc.1996-02-16
BACTEC CULTURE VIALS, LYTIC, ANAEROBIC (K954930)Becton Dickinson Diagnostic Instrument Systems1996-02-16
TEX-AID BLUE (K955856)Laborie Medical Technologies, Ltd.1996-02-16
TITANIUM MOSS MIAMI SPINAL SYSTEM (K955348)Depuy, Inc.1996-02-16
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 (K955934)Biosite Incorporated1996-02-16
BUDDY WHEELCHAIR (K960402)Metro-Care1996-02-16
ULTRAFLEX (K955347)Boston Scientific Corp1996-02-16
UNIQUE NEEDLE WITH FIRM GRIP SHIELD (K950666)Unique Management Ent., Inc.1996-02-16
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS (K954921)Becton Dickinson Diagnostic Instrument Systems1996-02-16
GC BASE W/ 1% GCHI (K954986)Remel, L.P.1996-02-16
GAMMA SYSTEM (K955473)Zimmer, Inc.1996-02-16
IMMULITE HGH (K955376)Diagnostic Products Corp.1996-02-16
VANCOMYCIN FPIA REAGENT SET (K955716)Sigma Diagnostics, Inc.1996-02-16
BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (K954925)Becton Dickinson Diagnostic Instrument Systems1996-02-16
IMMULITE ACTH (K960066)Diagnostic Products Corp.1996-02-16
NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET (K952852)Critical Device Corp.1996-02-16
CERALAS F ND:YAG LASER SYSTEM (K953851)Ceram Optec, Inc.1996-02-16
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS (K955277)Baxter Healthcare Corp1996-02-16
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS (K955935)Biosite Incorporated1996-02-15
HOWMEDICA BIOABSORBABLE PIN (K955806)Howmedica, Inc.1996-02-15
TOTAL CO2 (K951221)Randox Laboratories, Ltd.1996-02-15
BIOLOGIC-DT SYSTEM (K953751)Hemocleanse, Inc.1996-02-15
ACCU-CHEK ADVANTAGE TEST STRIPS (K954833)Boehringer Mannheim Corp.1996-02-15
EBNA ENZYME IMMUNOASSAY KIT (K951822)Granbio, Inc.1996-02-15
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) (K953915)Depuy, Inc.1996-02-15
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW (K954246)Acufex Microsurgical, Inc.1996-02-15
ACL-5500 PRECISION CURING UNIT (PCU) (K953898)Ion Laser Technology1996-02-15
INTERMOORE FRACTURE HIP STEM (K954854)Intermedics Orthopedics1996-02-15
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS (K954652)Aesculap, Inc.1996-02-14
BOSWORTH IMPRESSION MATERIAL I (K960063)Harry J. Bosworth Co.1996-02-14
GLYCAR STAPLE STRIPS (K954665)Glycar, Inc.1996-02-14
DG 88 (K960226)Degussa Corp.1996-02-14
SYSCON CONTROL ASSAYED & UNASSAYED (K954247)Scantibodies Laboratory, Inc.1996-02-14
CLP BONNET (K955528)Clp Products1996-02-14
ROTA-DAN RAPID ROTAVIRUS EIA KIT (K951208)Eldan Technologies, Ltd.1996-02-14
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T (K955868)Boehringer Mannheim Corp.1996-02-14
KEISEI (K950613)Keisei (Usa) Co., Ltd.1996-02-14
CPR SUPER POCKET PACK (K953230)Formosa-Cj Health Business Corp.1996-02-14
LFIC OR FETTO HIP (K952776)Zimmer, Inc.1996-02-14
MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS (K951846)Alphatec Mfg., Inc.1996-02-14
SPINE FIXATION (K943827)Danek Medical, Inc.1996-02-14
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM (K955793)Instrumentation Laboratory CO1996-02-14
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT (K954537)Olympus America, Inc.1996-02-14
LACTOSORB TRAUMA PLATING SYSTEM (K955729)Poly-Medics,Inc.1996-02-14
LINK MP RECONSTRUCTION HIP (K955296)Link America, Inc.1996-02-14
FINN KNEE SYSTEM (K945028)Biomet, Inc.1996-02-14
IMMILITE TOTAL IGE (K960067)Diagnostic Products Corp.1996-02-14
DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS (K953807)Stephen A. Dunn, Inc.1996-02-14
LORENZ MANDIBULAR DISTRACTOR (K955640)Biomet, Inc.1996-02-14
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (K955349)Meadox Medicals, Div. Boston Scientific Corp.1996-02-14
AUGMENT-T POSTERIOR SPINAL SYSTEM (K950717)Sofamor Danek USA,Inc.1996-02-14
CHROM Z-HEPARIN, CAT. NO 5242 (K952667)Helena Laboratories1996-02-14
SAS SPICER-EDWARDS 3 ANTISERUM (K955225)Sa Scientific, Inc.1996-02-13
AIA-PACK CPR ASSAY (K951848)Tosoh Medics, Inc.1996-02-13
INSULCAP (K952044)Karen Holtz1996-02-13
SAS SPICER-EDWARDS 2 ANTISERUM (K955224)Sa Scientific, Inc.1996-02-13
NEO-PNEUMOCATH (K955474)Intra Special Catheters GmbH1996-02-13
CARDON PHYSICAL THERAPY TABLE MODEL R27645 (K960336)Cardon Rehabilitation Products, Inc.1996-02-13
RESPITRACE PT (K942852)Non-Invasive Monitoring Systems, Inc.1996-02-13
RESPIEVENTS (K942771)Non-Invasive Monitoring Systems, Inc.1996-02-13
OMNI COLD GEL PACKS (K954877)Omni Therm, Inc.1996-02-13
SAS SPICER-EDWARDS 1 COMPLEX (K955222)Sa Scientific, Inc.1996-02-13
CARDON PHYSICAL THERAPY TABLE MODEL R28598 (K960332)Cardon Rehabilitation Products, Inc.1996-02-13
SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM (K953634)Shimadzu Medical Systems1996-02-13
SAS SPICER-EDWARDS 4 ANTISERUM (K955226)Sa Scientific, Inc.1996-02-13
CARDON PHYSICAL THERAPY TABLE MODEL R27116 (K960334)Cardon Rehabilitation Products, Inc.1996-02-13
RIA LATEX CONDOM (K943880)Mbf Personal Care Sdn. Bhd.1996-02-13
OLYMPUS BIPOLAR FORCEPS (K955623)Olympus America, Inc.1996-02-13
MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM (K960013)MDC Research , Ltd.1996-02-13
ROCHE REAGENT FOR GLUCOSE (K953847)Roche Diagnostic Systems, Inc.1996-02-13
SAS SPICER-EDWARDS 1 ANTISERUM (K955223)Sa Scientific, Inc.1996-02-13
LASERSONICS PARASCAN DOSIMETER DEVICE (K955734)Heraeus Surgical, Inc.1996-02-13
SAS SPICER-EDWARDS L COMPLEX (K955228)Sa Scientific, Inc.1996-02-13
DYNAMEQ-II OPTION (K955466)Qualitone1996-02-13
SAS SPICER-EDWARDS EN COMPLEX ANTISERUM (K955227)Sa Scientific, Inc.1996-02-13
NON APPLICATOR TAMPON, UNTREATED (K954445)Hygieia Healthcare , Ltd.1996-02-12
ALPHA MICRON 20 MICROAGGREGATE FILTER (K955515)Alpha Therapeutic Corp.1996-02-12
EURO SC500 (K944940)Pride Health Care, Inc.1996-02-12
B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE (K955235)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-02-12
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) (K954284)Medi-Plast Intl., Inc.1996-02-12
JPI AUTOMATIC X-RAY FILM PROCESSOR (K955706)Jpi Healthcare Co, Ltd.1996-02-12
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS (K955407)Sims Deltec, Inc.1996-02-12
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) (K952892)Olympus America, Inc.1996-02-12
SURGIFLATOR 20 (K950035)W.O.M. GmbH1996-02-12
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Every clearance here is in the API, with alerts when new ones post.