FDA 510(k) clearances — page 989
clearances on record, most recent first.
Clearances — page 989
98,801–98,900 of 175,890- K961277 — RF IGM ELISA TEST SYSTEM
- K961284 — KOLOR +
- K961471 — INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
- K944598 — GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL
- K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY
- K950330 — DIGITAL IMAGE ACQUISITION SYSTEM
- K952675 — ORTHOFAB WHEELCHAIR
- K952966 — CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
- K953165 — ULTRA COMPACT VIDEO IMAGER
- K954957 — CODEMASTER XL + XL W/SHOCK ADVISORY OPTION
- K955635 — VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
- K960357 — DSL ACTIVE I-HCG IRMA
- K960575 — ADVANTX LCV+
- K960665 — ECHO-COM FOR MS-WINDOWS VERSION 2.0
- K960711 — ACUMED BONE GRAFT SYSTEM
- K960741 — COMFORTONE PHS
- K960872 — CYSTOSCOPE 0/15/30/70 DEGREES
- K960946 — ECHONET
- K961059 — DIGIFOCUS COMPACT
- K961082 — TECHNA TONE
- K961099 — EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
- K961115 — EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
- K961143 — TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
- K961226 — EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
- K961244 — KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME
- K961308 — AUDIO 'D' INTIMA CIC
- K961473 — HM-88011 SOLID STATE ELECTR SURGICAL UNIT
- K961514 — BCW ADVANTAGE WHEELCHAIR
- K935833 — LCX NEISSERIA GONORRHOEAE ASSAY
- K955282 — THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
- K955332 — OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW
- K955410 — SNAPDOSE DEVICE
- K960178 — COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
- K960616 — VITAFLOW SUCTION/ASPIRATION TUBING SET
- K960624 — CERTI COOL INSTANT COLD COMPRESS
- K960664 — BARBITURATE SERUM TOX EIA ASSAY
- K960697 — ULTRACID AND ULTRACID F DISINFECTING SOLUTION
- K960963 — CORD WRAP WITH NEEDLE RESHEATHER
- K961005 — SARGON IMMEDIATE LOAD IMPLANT
- K961043 — SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
- K961474 — POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133
- K950484 — TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
- K953682 — IMMUNO DOT BORRELIA DOT BLOT G TEST
- K953683 — MMUNO DOT BORRELIA DOT BLOT M TEST
- K954221 — POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
- K954267 — BURDICK 200 PULSE OXIMETER
- K955573 — OPTIBLAST INTRAORAL SANDBLASTER
- K960107 — DDS SPINAL SYSTEM
- K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV
- K960651 — CERCLAGE WIRE CRIMP BLOCK
- K960655 — AESOP SYSTEM AND ACCESSORIES
- K960678 — BURCH/SCHNEIDER REINFORCEMENT CAGE
- K961022 — TANGENT VI TABLE
- K961098 — BIO-DRESSING, STERILE ISLAND DRESSING
- K934695 — NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA
- K953452 — KETOREX C SANWA
- K954828 — ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
- K955684 — RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
- K955707 — ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
- K960180 — 22 MM COCR HEAD & POLYETHLENE LINER
- K960377 — ENA-C-T TOTAL CHOLESTEROL TEST
- K960427 — ABBOTT CELL-DYN 3500R SYSTEM
- K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
- K960806 — TURBO TRACKER
- K961293 — QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
- K955382 — 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
- K960080 — ACCUTEMP PROBE
- K960519 — MARTECH ENDOSCOPIC INJECTION NEEDLE
- K960733 — MINISTICK PREGNANCY TEST
- K960757 — KARL STORZ URETER RESECTOSCOPE
- K961372 — SERUM TOX CALIBRATOR
- K950646 — INTEGRATOR
- K952631 — BRAUN HEMODIALYSIS BLOOD CIRCUITS
- K953300 — V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER
- K954158 — STC DIAGNOSTICS AUTO-LYTE PH ASSAY
- K954171 — ARCO-MBC, ARCO MC
- K954506 — EMOX
- K954570 — ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
- K955247 — OLYMPUS KD SERIES SPHINCTEROTOME
- K955397 — MAYFIELD-ACCISS WORKSTATION
- K960001 — MINIMED INFUSION PUMP, MODEL MMT-507
- K960581 — SECURE EVA DUAL CHAMBER MIXING BAG
- K960613 — GE ADVANTAGE WINDOWS REVIEW WORKSTATION
- K960694 — ZOMED 30F ELECTROSURGICAL PROBE
- K960695 — MODEL 200C ELECTROSURGICAL PROBE
- K960825 — LM ANCHOR OR OTHER PROPRIETARY NAME
- K961074 — LIGHTSOURCE OR ILLUMINATOR
- K961135 — INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
- K961185 — DAUM BIOPSYNEEDLE
- K961441 — TONOMETERED SLAINE BLOOD GAS CONTROL
- K943145 — AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE
- K951549 — EBNA IGG EIA TEST SYSTEM
- K954552 — RAILWIRE
- K954622 — IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK
- K954903 — PEDI VAGINAL ASPIRATOR
- K955093 — ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
- K960040 — SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
- K960316 — CLEARBLUE EASY
- K960381 — MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
- K960563 — SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
Data sourced from openFDA. This site is unofficial and independent of the FDA.