Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MEDI GUARD DRAPES (K911950)Sancella, Inc.1991-05-21
ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012 (K910845)Interventional Therapeutics Corp.1991-05-21
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP (K911289)Baxter Healthcare Corp1991-05-21
CELL SWEEP (K911327)Reza S Mohajer, M.D. C/O Krass & Young1991-05-21
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE (K910708)Rich-Mar Corp.1991-05-21
HALE SUN SURGICAL TOWEL OR O.R. TOWEL (K905803)Hale Sun Industries, Ltd.1991-05-21
VILLAN (VIDEO LIFT LINK ANALYSIS) (K910712)Physio Systems, Inc.1991-05-21
REDDICK TROCAR AND CANNULA (K911601)Ideal Medical, Inc.1991-05-21
S-ROM OBLONG ACETABULAR CUP (K905258)Joint Medical Products Corp.1991-05-21
ADP REAGENT (K910800)Helena Laboratories1991-05-20
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY (K904253)Ortho Diagnostic Systems, Inc.1991-05-20
CPR BAG (K911622)Merced Medical, Inc.1991-05-20
COLLAGEN REAGENT CAT. NO. 5368 (K910706)Helena Laboratories1991-05-20
HYPODERMIC NEEDLES, SINGLE LUMEN (K911397)Popper & Sons, Inc.1991-05-20
FRANKLIN 9000 WALL STAND (K905789)Mallinckrodt Group, Inc.1991-05-20
HYGIENA-TRACH (K911080)Apdyne Medical Co.1991-05-20
MUCAID (K910909)Vygon Corp.1991-05-20
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING (K910908)Vygon Corp.1991-05-20
EPINEPHRINE REAGENT, CAT. NO. 5367 (K910680)Helena Laboratories1991-05-20
ENZYGNOST ANTI-CMV/IGG + IGM (K901485)Behring Diagnostics, Inc.1991-05-20
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING (K910791)Kendall Healthcare Products Co. Div.Of Tyco Health1991-05-17
CHAMPION, BEHIND-THE-EAR HEARING AID (K911705)Electone, Inc.1991-05-17
JUZO-RESPIRA ANTI-EMBOLISM STOCKING (K905413)Julius Zorn, Inc.1991-05-17
AUGUSTINE STYLET (K910659)Augustine Medical, Inc.1991-05-17
KODAK EKTASCAN CABLE EXTENSION (K911437)Eastman Kodak Company1991-05-17
ZINETICS INTERNAL REFERENCE PROBE (K910694)Zinetics Medical, Inc.1991-05-17
STOCK CANAL, IN-THE-EAR HEARING AID (K911709)Electone, Inc.1991-05-17
LATEX EXAM GLOVES-POWDER FREE (K910949)Zhongmin (Fujian) Machinery & Electrical Equipment1991-05-17
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM (K910859)Siemens Medical Solutions USA, Inc.1991-05-17
MODEL 800, BEHIND-THE-EAR HEARING AID (K911706)Electone, Inc.1991-05-17
REGAL, BEHIND-THE-EAR HEARING AID (K911707)Electone, Inc.1991-05-17
ECAT SCANNER (K910048)Cti Pet Systems, Inc.1991-05-17
MODEL E-50, IN-THE-EAR HEARING AID (K911708)Electone, Inc.1991-05-17
TORQUE DEVICE FOR A GUIDE WIRE (K910969)Terumo Corp.1991-05-16
WARMAIR SYSTEM (K910327)Cincinnati Sub-Zero Products, Inc.1991-05-16
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS (K911122)Intermedics, Inc.1991-05-16
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE (K905824)Cardiac Control Systems, Inc.1991-05-16
CORDIS PEEL-AWAY INSERTION TOOL (K910688)Cordis Corp.1991-05-16
XEMEX TEMPORARY PACING CATHETER A (K904868)Zeon Medical Corp.1991-05-16
RMI VASCULAR TOURNIQUET KIT (K910221)Research Medical, Inc.1991-05-16
MODIFIED PYROGEN TESTING (K910935)Electromedics, Inc.1991-05-16
NATIVE PROTHROMBIN ANTIGEN EIA (K910617)Organon Teknika Corp.1991-05-15
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES (K910781)Midmark Corp.1991-05-15
BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS (K902968)Core-Vent Corp.1991-05-15
PROTEKT GLOVES (K910920)Intermedics Orthopedics1991-05-15
G-FLOSS & G-FLOSS II (K911701)Implant Innovations International, Inc.1991-05-15
29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM (K911068)Micro Motors, Inc.1991-05-15
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION (K911578)Cholestech Corp.1991-05-15
MERCURY AND GLASS FEVER THERMOMETER (K911269)Steridyne Corp.1991-05-15
TASSI MK3 (TURNAIR) (K910851)Therapy Air Support Systems, Inc.1991-05-15
ADVANTX AFM ANGIO SYSTEM S1808 (K905653)GE Medical Systems1991-05-15
PULPDENT PIC N STIC (K911281)Pulpdent Corp.1991-05-15
BUFFING FLOSS (K911470)Lamar Industries1991-05-15
ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN (K911558)Alamar Biosciences Laboratory, Inc.1991-05-15
STRATUS(R) AUTOMATED SAMPLE HANDLER (K911712)Baxter Healthcare Corp1991-05-15
URODYNAMIC MEASURING SYSTEM (K910371)Browne Medical Systems, Inc.1991-05-15
VISION BG MONITOR (K911596)British-American Medical, Inc.1991-05-15
TOKUSO LIGHT BOND (K911525)Tokuyama America, Inc.1991-05-15
CEDIA(R) DIGOXIN R' ASSAY (K911941)Microgenics Corp.1991-05-15
SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR (K911072)A & F Products1991-05-15
SONOPAK/QS, SONOPAK (K905657)Bioresearch1991-05-15
FIRST CHOICE(TM), MODIFICATION (K911792)Polymer Technology Corp.1991-05-15
TOTAL BILIRUBIN REAGENT SET (K910635)Biochemical Trade, Inc.1991-05-15
MIRCOLINE SCREEN FOR COCAINE (K911652)Drug Screening Systems, Inc.1991-05-15
QDR-1000 AND WITH X-RAY BONE DENSITOMETER (K905691)Hologic, Inc.1991-05-15
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED (K911803)Hichem Diagnostics1991-05-15
CLEARVIEW HCG SERUM/URINE (K905741)Unipath , Ltd.1991-05-15
FOUNDATION HYBRID COMPOSITE (K904135)Nulite Systems Research1991-05-15
MODEL STT-100 (K904853)Sonocare, Inc.1991-05-15
504US PULSE OXIMETER (K910770)Criticare Systems, Inc.1991-05-14
DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) (K902607)Dantec Medical, Inc.1991-05-14
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM (K905397)Puritan Bennett Corp.1991-05-14
AP-860PA NIBP MODULE (K910629)Nihon Kohden America, Inc.1991-05-14
PATHFINDER (K910601)Nurion Industries1991-05-14
SPARK KIT(R), MODIFICATION (K910142)Lyphomed, Inc.1991-05-14
TENS CONDUCTIVE MEDIA PAD (K904889)Creative Design Systems, Inc.1991-05-14
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM (K910194)Puritan Bennett Corp.1991-05-13
PRECISION GLIDE - ENHANCED SURGICAL BLADE (K911913)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-05-13
INVOTEC EAR DRAPE (K911039)Invotec International, Inc.1991-05-13
PS OMNIFIT NORMALIZED HIP STEM SERIES (K910662)Osteonics Corp.1991-05-13
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS (K911108)G.W.B. Intl., Ltd.1991-05-13
MENS-O-MATIC 2000 (K904235)Monad Corp.1991-05-13
MENS-O-MATIC 3000 (K904260)Monad Corp.1991-05-13
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER (K911369)Deroyal Industries, Inc.1991-05-13
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM (K905404)Medtronic Vascular1991-05-13
MODIFIED AEROCHAMBER WITH MASK (K900576)Monaghan Medical Corp.1991-05-13
MENTOR(R) SUR-E-TROL(R) (K910637)Mentor O & O, Inc.1991-05-13
INTRAVASCULAR IMAGING SYSTEM/MODIFIED (K910281)Intertherapy, Inc.1991-05-13
MENS-O-MATIC I (K904234)Monad Corp.1991-05-13
PUMP VAC PLUS (K910907)Marlo Surgical Technology1991-05-13
DISPOSABLE ISOLATION GOWN (K911921)Liaoning-Usa Corp.1991-05-13
MINISCOPE (K910587)Citation Medical Corp.1991-05-13
MICRO DERM (K904258)Monad Corp.1991-05-13
MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS (K904288)Monad Corp.1991-05-13
MENS FREEDOM MICRO (K904430)Monad Corp.1991-05-13
SUPERSERUM REAGENT (SSR) (K910646)International Technidyne Corp.1991-05-10
UCEZ - STERILE LENS FOG REDUCTION DEVICE (K905590)Inman Liebelt Corp.1991-05-10
HITT BY HEMOCHRON(R) (K910181)International Technidyne Corp.1991-05-10
BACTI-SWAB (K910180)Remel Co.1991-05-10
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST (K911145)Medical Diagnostic Technologies, Inc.1991-05-10
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Every clearance here is in the API, with alerts when new ones post.