Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HLE-1000 HIGH/LOW TREATMENT TABLE (K883659)Rich-Mar Corp.1988-10-13
LARYNGOSCOPE (K883296)Lothar Scharras1988-10-13
IRIS ND:YAG OPTHALMIC LASER (K883270)California Laboratories, Inc.1988-10-13
MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (K884032)Morgan Associates, Inc.1988-10-13
ACUFEX INTERFERENCE SCREW AND SCREWDRIVER (K883910)Acufex Microsurgical, Inc.1988-10-12
KVM HEMOGLOBIN LYSING REAGENT (K883991)Kvm Technologies, Inc.1988-10-12
ORTHO-SEAL (K883465)Bisco, Inc.1988-10-12
PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE (K874923)Howmedica Corp.1988-10-12
TRACER BONE MILL (K883183)De Medica Mfg., Inc.1988-10-12
MAXERECT (K881008)Kenneth Chapman1988-10-12
AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 (K882551)Intl. Biomedics, Inc.1988-10-12
DENTAL CHAIR (K883437)E.F. Brewer Co.1988-10-12
HYDRAMED BY LECHLER (K882953)Lechler, Inc.1988-10-12
LAKE FOLEY CATHETERIZATION TRAY (K883610)Lake Medical Products, Inc.1988-10-12
KVM ISOTONIC FLUSH SOLUTION (K883989)Kvm Technologies, Inc.1988-10-12
EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO) (K883242)Cancer Technologies, Inc.1988-10-12
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL (K883798)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-12
X-ACT LDC/IND (K883996)Pro-Lab, Inc.1988-10-12
KVM ISOTONIC DILUENT (K883990)Kvm Technologies, Inc.1988-10-12
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS (K883792)Catachem, Inc.1988-10-12
MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL (K881259)Triton Biosciences, Inc.1988-10-12
KVM PREPACK HEMATOLOGY REAGENT SET (K883992)Kvm Technologies, Inc.1988-10-12
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL (K883800)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-12
MODIFIED BETA QUIK STAT EIA KIT (K882895)Pacific Biotech, Inc.1988-10-12
MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) (K883416)Scott All-Sports, Inc.1988-10-12
STERILE SURGEONS GLOVES (K883736)Medical Manufacturers Marketing Co.1988-10-12
ALBABOND 60 (K883758)Degussa Dental, Inc.1988-10-12
DIGITRON STENOSIS PROTOCOL (K881481)Siemens Gammasonics, Inc.1988-10-12
TONOMITOR (TM) + SUMP (K883234)Tonometrics, Inc.1988-10-12
QUIDEL GROUP A STREP TEST (K883999)Quidel Corp.1988-10-12
100-01778-52 ULTRASOUND SYSTEM (K882478)Diasonics, Inc.1988-10-12
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (K883307)Hospal Medical Corp.1988-10-12
KOLYNOS DENTAL FLOSS (K882571)Whitehall Laboratories, Inc.1988-10-12
X-ACT UREA/TDA (K883995)Pro-Lab, Inc.1988-10-12
TECNOL BUCKS TRACTION W/HEEL PROTECTOR (K884132)Technol, Inc.1988-10-11
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A (K883920)Syva Co.1988-10-11
PROTECT-AIDS AUTOPSY UNDERGLOVE (K880440)Medical Armor Corp.1988-10-11
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE (K884022)Syva Co.1988-10-11
PROTECT-AIDS UNDERGLOVE (K880439)Medical Armor Corp.1988-10-11
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA (K882736)Amersham Corp.1988-10-11
FOCUS TOTAL HIP SYSTEM (K883460)Depuy, Inc.1988-10-11
SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25 (K883264)Philips Medical Systems, Inc.1988-10-11
P-7 COMPUTED TOMOGRAPHY SYSTEM (K882378)Philips Medical Systems (Cleveland), Inc.1988-10-11
TDX CANNABINOIDS-GS (K883731)Abbott Laboratories1988-10-11
DVS (OPTION 01) (K883101)O.M.I. Oncology Microsystems, Inc.1988-10-07
MASTER-GUARD (K884041)Sparco, Inc.1988-10-07
LENZ CLENZER (K881739)Lens Care, Inc.1988-10-07
VIADERM (K882590)Applied Biomedical Sciences1988-10-07
DIASONICS MT/P IMAGING SYSTEM (K883516)Diasonics, Inc.1988-10-07
ROCKET CERVICAL SPATULA (K884042)A & A Medical, Inc.1988-10-07
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER (K873674)Shimadzu Corp.1988-10-07
SUREBREATH DOME (K884076)Ipax, Inc.1988-10-07
TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER (K883546)Advanced Technology Laboratories, Inc.1988-10-07
0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST (K883520)Philips Medical Systems (Cleveland), Inc.1988-10-07
15 MILLIMETER MALE AND FEMALE ADAPTERS (K884072)Eastmed Enterprises, Inc.1988-10-07
NON-REBREATHING TEE PIECE (NRTP) (K883988)Dhd Medical Products Div. Diemolding Corp.1988-10-07
WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE (K883876)E.G. Dick & Assoc.1988-10-07
RANEY AND LEROY-RANEY SCALP CLIP (K883963)New England Surgical Instrument Corp.1988-10-07
AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR (K883483)Autoflow Products, Co.1988-10-07
BINAS LUTEINIZING HORMONE IRMA TEST KIT (K883306)Binax, Inc.1988-10-06
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER (K883297)Hewlett-Packard Co.1988-10-06
MICROMEDIC CRACKPOT RIA KIT (K880674)Icn Micromedic Systems1988-10-06
B. FRAGTEX (K881380)American Biomedical Products, Inc.1988-10-06
BLUE DOT(TM) TEST FOR PREGNANCY (K882588)V-Tech, Inc.1988-10-06
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP (K883015)Cardiac Control Systems, Inc.1988-10-06
FIRST MEDIC MODE 610 (K883584)First Medical Devices Corp.1988-10-06
HISTO-CHECK FUNGAL CONTROL SLIDES (K883570)Val Tech Diagnostics, Inc.1988-10-06
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (K883352)Whittaker Bioproducts, Inc.1988-10-06
LANTOR CUBE STERILIZER TEST PACK (K882756)Lantor Group1988-10-06
HEMOGLOBIN (K883683)Tech-Co, Inc.1988-10-06
HISTO-CHECK LEGIONELLA CONTROL SLIDES (K883567)Val Tech Diagnostics, Inc.1988-10-06
PACER SENSING ANALYZER (PSA 100) (K882327)Oscor Medical Corp.1988-10-06
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT (K881983)Howmedica Corp.1988-10-06
CLEARVIEW HCG (K883777)Unipath , Ltd.1988-10-06
FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (K884031)Regency Biotech1988-10-06
BARD MULTI-TAC ECG MONITORING ELECTRODE (K884064)C.R. Bard, Inc.1988-10-06
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY (K883305)Binax, Inc.1988-10-06
POCKET MANOMETER (K880599)Abbott Laboratories1988-10-06
HISTO-CHECK GRAM NEGATIVE SLIDES (K883569)Val Tech Diagnostics, Inc.1988-10-06
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 (K882728)Amersham Corp.1988-10-06
ALBABOND E (K883511)Degussa Dental, Inc.1988-10-06
ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER (K884139)Medical Safety Products, Inc.1988-10-06
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL (K883147)Utak Laboratories, Inc.1988-10-06
USCI SOFT-TIP ANGIOGRAPHIC CATHETER (K883051)C.R. Bard, Inc.1988-10-06
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200 (K882475)Amersham Corp.1988-10-06
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR (K882380)Scimed Life Systems, Inc.1988-10-06
HISTO-CHECK PARASITIC CONTROL SLIDES (K883571)Val Tech Diagnostics, Inc.1988-10-06
DENTREK BRIDGE BARS (K883388)Dale T. Dupuis1988-10-06
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST (K883936)Ortho Diagnostic Systems, Inc.1988-10-06
HISTO-CHECK ACID FAST SLIDES (K883568)Val Tech Diagnostics, Inc.1988-10-06
CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST (K882199)Auspharm Intl. , Ltd.1988-10-06
CHLORIDE (K883386)Tech-Co, Inc.1988-10-06
MODIFIED HCG IRMA KIT (K883639)Pacific Biotech, Inc.1988-10-06
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE (K883523)Cardiotronics, Inc.1988-10-06
SNAP N' STAIN IRON STAIN (K884011)Scientific Device Laboratory, Inc.1988-10-06
TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 (K882904)Tdk Corp.1988-10-05
POLY-TAC (K882235)Cardiovascular Group, Inc.1988-10-05
BREVET DENTAL INSTRUMENTS (K883126)Brevet, Inc.1988-10-05
PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR (K883965)Teknar, Inc.1988-10-05
SKINCOTE (K882567)Dynarex Corp.1988-10-05
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