Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
C.A.B. RING (K894268)Medi-Sharp, Inc.1989-08-17
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR (K894185)Telectronics Pacing Systems, Inc.1989-08-17
SYSTEM 2500 MEDICAL WATERBED (K894723)Dermanetics Corp.1989-08-17
PATIENT EXAMINATION GLOVES (K892974)Dubo Latex , Ltd.1989-08-17
USCI PROBING CATHETER (K890152)C.R. Bard, Inc.1989-08-17
AMYLASE TEST (AML) ITEM NUMBER: 65404 (K893751)Em Diagnostic Systems, Inc.1989-08-17
STERILE LATEX EXAM GLOVES (K894676)Superior Healthcare Group, Inc.1989-08-17
SHIELDS T.C. LASER LENS (K893731)Ocular Instruments, Inc.1989-08-17
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER (K893741)Abbott Laboratories1989-08-17
LATEX EXAMINATION GLOVES (K894635)Ever-More Latex Products Sdn Bhd1989-08-17
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE (K894084)Target Therapeutics1989-08-17
IFA SENSIBAC CEPHALOTIN (K892735)Investigacion Farmaceutica S.A. DE C.V.1989-08-17
USCI PROBE LINX EXTENSION WIRE (K890404)C.R. Bard, Inc.1989-08-17
IFA SENSIBAC NALIDIXIC ACID (K892713)Investigacion Farmaceutica S.A. DE C.V.1989-08-17
PATIENT EXAMINATION GLOVES (LATEX) (K892268)Jinnwah Ent., Inc.1989-08-17
CENTRALITE BACKPOINTER (K893398)Diacor, Inc.1989-08-17
KDF-2.3 (K894264)Unimar, Inc.1989-08-15
SALMONELLA IFA* (K885114)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
DALE I.V. IDENTIFIER; PRODUCT #1125 (K894586)Dale Medical Products, Inc.1989-08-15
INNOFLUOR CARBAMAZEPINE CALIBRATOR SET (K893506)Innotron of Oregon, Inc.1989-08-15
FD 300 DENTAL STOOL (K893944)Oriola OY Finndent1989-08-15
MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP (K894362)Spectramed, Inc.1989-08-15
COULTER CLONE MO2 (K884605)Coulter Immunology1989-08-15
DECONTAMINATING KIT, SKIN: M291 (K894455)Dept. of the Army1989-08-15
HGB-CAL SET/MULTIPLE (K893984)R&D Systems, Inc.1989-08-15
CHLAMYDIA (LGV-1) (K894625)Bion Ent., Ltd.1989-08-15
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM (K892206)Mardx Diagnostics, Inc.1989-08-15
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE (K894465)Roche Diagnostic Systems, Inc.1989-08-15
KENDALL CURITY OXYGEN MASK (K892434)The Kendal Co.1989-08-15
LEECO VIS-DISK STREP-A (EIA) (K894122)Leeco Diagnostics, Inc.1989-08-15
BRUCELLA IFA* (K885112)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
MODEL 0450000, OPAL MEDICAL EXAM LIGHT (K893808)Burton Medical Products Corp.1989-08-15
CHLORIDE STANDARDS ITEM #SR1041 (K891999)Em Diagnostic Systems, Inc.1989-08-15
HIBERNATION KIT (K892660)Devon Industries, Inc.1989-08-15
ABSOLUTE(TM)-HCG URINE PREGNANCY TEST (K893953)Totem Diagnostics, Inc.1989-08-15
ROBOTIC SAMPLE PROCESSOR (K894126)Tecan U.S., Ltd.1989-08-15
FD4500 (DENTAL CHAIR) (K893890)Oriola OY Finndent1989-08-15
STERILIZATION TRAY LINER (K893764)Ahlstrom Dexter1989-08-15
SIL-MED WASTE FLUID DUMP BAG (K891471)Sil-Med Corp.1989-08-15
MERIVIEW TM TRICHOMONAS (K894246)Meridian Diagnostics, Inc.1989-08-15
HGB-CONTROL SET/MULTIPLE (K893985)R&D Systems, Inc.1989-08-15
DIDECO-SHILEY UNIVERSAL Y (K894294)Shiley, Inc.1989-08-15
PATIENT EXAM GLOVES (MFG. M.R. RUBBER INDUSTRIES) (K891815)Mulpha Intl. Trading Corp. Bhd.1989-08-15
IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL (K885113)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
PATIENT EXAMINATION GLOVE (K890594)Tradexim Sdn Bhd1989-08-15
BECKMAN CHOLINESTERASE REAGENT KIT (K893583)Beckman1989-08-15
DUBBLE BUTTERFLY PAT EXAM GLOVES/MFG: QUINGDAO FAC (K893236)China National Chemical Construction Corp.-Qingdao1989-08-15
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID (K893528)Oticon Corp.1989-08-15
CLINISTAT TOTAL BILIRUBIN REAGENT TEST (K892801)Heraeus Kulzer, Inc.1989-08-15
FD3500 (DENTAL CHAIR) (K893889)Oriola OY Finndent1989-08-15
PROTEUS OX-19 IFA* (K885110)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
CAPTIA(R) RUBELLA-G (K883924)Mercia Diagnostics , Ltd.1989-08-15
DENLEY WELLWASH 2 AND 4 (K894271)Denley Instruments, Inc.1989-08-15
FD 200 DENTAL STOOL (K893943)Oriola OY Finndent1989-08-15
ABBOTT SPECTRUM AMYLASE REAGENT (K891241)Abbott Laboratories1989-08-15
MODIFIED PK300 AUTOMATIC EIA ANALYZER (K893768)Olympus Corp.1989-08-15
IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT (K882674)Icn Immunobiologicals1989-08-15
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS (K891581)Roche Diagnostic Systems, Inc.1989-08-15
SOFT LENS FOLDING BLOCK (K891487)Western Medical Products, Inc.1989-08-15
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT (K893469)Amersham Corp.1989-08-15
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST (K894279)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-08-15
TARGET(TM) CK-MB (K890295)V-Tech, Inc.1989-08-15
CAPTIA(R) RUBELLA-M (K885300)Mercia Diagnostics , Ltd.1989-08-15
IFA SENSIBAC GENTAMYCIN (K892720)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
RUBBER TREE BRAND (K894214)Jinmei International, Inc.1989-08-15
TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF (K893519)Statlabs, Inc.1989-08-15
IFA SENSIBAC PENICILLIN (K892726)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
GONOSTAT (K883486)Technology Management & Marketing, Inc.1989-08-15
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS (K893977)Baxter Healthcare Corp1989-08-15
MODEL 0183010, PEARL MEDICAL EXAM LIGHT (K893807)Burton Medical Products Corp.1989-08-15
PREPOWDERED VINYL EXAM GLOVES (K893334)Dynarex Corp.1989-08-15
GE SIGNA ADVANTAGE (K893509)GE Medical Systems1989-08-11
GOMCO CIRCUMCISION CLAMP (K894201)Zinnanti Surgical Instruments, Inc.1989-08-11
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS (K894278)Storz Instrument Co.1989-08-11
INNOFLUOR CARBAMAZEPINE REAGENT SET (K893507)Innotron of Oregon, Inc.1989-08-11
FD 350 DENTAL STOOL (K893945)Oriola OY Finndent1989-08-11
UROPUMP* FLUID MANAGEMENT SYSTEM (K894363)Orthoconcept, Inc.1989-08-11
T3 CLASP-BEAD EIA KIT (K893620)Biotecx Laboratories, Inc.1989-08-11
CONDOMS (K880819)Universal Trade, Inc.1989-08-11
FLOCARE (K893875)Mega-Tech Intl., Inc.1989-08-11
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE (K894404)Syva Co.1989-08-11
BATES BLANKET (K894433)Joe B. Bates, MD, FAAP1989-08-11
DENTANURSE (K891607)The Irish Scene1989-08-11
PEAK FLOW RATE METER (K893827)Laytech Medical Co.1989-08-11
SHIRT, OPERATING, SURGICAL (K894599)Miroz Industries Co.1989-08-11
MASCOT O.R. TOWEL (K894436)Mascot, Inc.1989-08-11
XENOS MOBILECAM (K893379)Xenos Medical Systems, Inc.1989-08-11
OLYMPUS ISE MODULE FOR AU5000 (K893628)Olympus Corp.1989-08-11
SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS (K894042)Labeltape Meditect, Inc.1989-08-11
TRACER DYNAMIC AXIAL FIXATION (K892638)Tracer Medical1989-08-11
QUIDEL REFLECTANCE ANALYZER (K893738)Quidel Corp.1989-08-11
STERILE HAND COVER (K894064)Sage Products, Inc.1989-08-11
ANESTHETIC GAS MONITOR (K890446)Bruel & Kjaer Instruments, Inc.1989-08-11
DERMACARE TIE HOLDER (K893995)Dermacare1989-08-11
SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS (K894043)Labeltape Meditect, Inc.1989-08-11
PATIENT EXAM GLOVES (MFG. TA TA INDUSTRIAL CO.) (K892473)Mccampbell Ent. Unltd., Inc.1989-08-11
LAURIER SANITARY NAPKIN (K893773)Kao Corp.1989-08-11
ROCHE REAGENT FOR TRIGLYCERIDES (K893973)Roche Diagnostic Systems, Inc.1989-08-11
DIRECT BILIRUBIN REAGENT (K893730)Medical Analysis Systems, Inc.1989-08-11
3D DENTAL DIAMOND ROTARY INSTRUMENTS (K893844)Lustgarten Multi-Tech International, Inc.1989-08-11
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Every clearance here is in the API, with alerts when new ones post.