FDA 510(k) clearances — page 837
clearances on record, most recent first.
Clearances — page 837
83,601–83,700 of 175,890- K000538 — MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
- K990897 — NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
- K990975 — IN-LINE HEMOSTASIS VALVE
- K993358 — SIGHTSURE OPERATION INDICATOR, MODEL SS301
- K993656 — DATEX-OHMEDA TONOMETRY MODULE M-TONO
- K993938 — THE HOMMED SENTRY, MODEL 1 SENTRY
- K994015 — ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
- K994242 — BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
- K994347 — CENTAUR SPINAL SYSTEM
- K994364 — SYNTHES BUTTON PLATE
- K000014 — BARCOMED 5MP1H
- K000016 — BARCOMED 5MP2
- K000311 — PARAPOST FIBER WHITE
- K000502 — STEAM/EO RECORD CARD, MODEL CI 121
- K000554 — POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET
- K000589 — MODEL 445SI-64E QUADRATURE WRIST COIL
- K000675 — MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
- K993280 — PROSTEC 125I BRACHYTHERAPY SEEDS
- K994254 — INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
- K994285 — ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH
- K994357 — BITEM LOCK, MODELS SW006, SW012
- K994368 — AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
- K994436 — SURGI-VISION ESOPHAGEAL STYLET COIL
- K000054 — FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
- K000068 — COMPUMEDICS E-SERIES EEG SYSTEM
- K000171 — CBYON SURGICAL OPERATING SYSTEM (SOS)
- K000309 — BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
- K000490 — CYNOSURE PHOTOGENICA VLS-STAR
- K000498 — COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
- K000511 — MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS
- K000628 — WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
- K991413 — CODMAN ETHISORB DURA PATCH
- K992655 — FERTILOSCOPY KIT FH 1.29/FTO 1.40
- K993024 — CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
- K993362 — HYLASINE
- K993568 — MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
- K994157 — DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
- K994207 — HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
- K994365 — DYONICS ELECTROBLADE
- K000009 — SPIRAL RADIUS RODDING SYSTEM
- K000058 — BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES
- K000091 — DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
- K000165 — NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K000450 — MODIFICATION TO SYNTHES USS
- K000453 — MODIFICATION TO CD SPINAL SYSTEM
- K000476 — MODIFICATION TO CD SPINAL SYSTEM
- K000575 — GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
- K000634 — ROD TO ROD CROSS BRACES
- K992821 — SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K992850 — MAGELLAN TIBIAL INTRAMEDULLARY NAIL
- K992856 — MAGELLAN HUMERAL INTRAMEDULLARY NAIL
- K993259 — INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
- K993805 — NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED)
- K994286 — ZMR HIP SYSTEM-POROUS REVISION
- K994382 — NONLINEAR TAPER LAG SCREW
- K994392 — AEQUALIS SHOULDER FRACTURE SYSTEM
- K000544 — BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
- K000566 — MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
- K000567 — ULTRASOUND SCANNER TYPE 2102
- K000656 — EMBRYON GIFT TRANSFER CATHETERS/SETS
- K992762 — BRACHYVISION 6.0
- K993946 — PEGASYS ULTRA
- K994270 — INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
- K000497 — VOYAGER/VIPER WHEELCHAIR
- K000657 — LUER ACCESS UNIVERSAL VIAL ADAPTER
- K982558 — BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
- K990718 — ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
- K990831 — SUPERGUARD SAFETY SYRINGE
- K991271 — OOCYTE ASPIRATION NEEDLE
- K992912 — CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
- K992933 — LEMAITRE IRRIGATION CATHETER
- K993691 — ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
- K993894 — LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
- K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET
- K994375 — HORIZON LIGHT
- K000250 — CAUTERY FORCEPS WITH FOOTSWITCH
- K000270 — ELECSYS CORTISOL TEST SYSTEM
- K000296 — STARION CAUTERY HOOK
- K000397 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
- K000425 — ISOBAR SPINAL SYSTEM
- K000447 — QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
- K000513 — MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
- K000608 — SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
- K991470 — MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)
- K992386 — ALLON 2000
- K993456 — SAS STREP A TEST
- K993584 — MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
- K994167 — CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)
- K994378 — AIRIS II
- K994428 — E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
- K000384 — FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
- K000482 — MODIFICATION TO AUTOJECT MINI
- K991798 — ACME MEDICAL AESTHETIC ND:YAG LASER
- K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
- K994128 — SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
- K994142 — GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
- K994152 — THE LIGAMENT ANCHOR SOFT SCREW
- K994203 — ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
- K994299 — ART-P3, MODEL P3-1-ART-A1
- K994363 — INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.