FDA 510(k) clearances — page 686
clearances on record, most recent first.
Clearances — page 686
68,501–68,600 of 175,825- K041605 — PRECISION RXI ANALOG X-RAY SYSTEM
- K041686 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
- K040952 — PRELUDE
- K041204 — NC SP02 ADAPTER CABLE
- K041471 — G-BOND
- K041580 — IMAGERAYI
- K033118 — BIPRO MODEL SDS-CB200
- K040511 — SCD EXPRESS PORTABLE COMPRESSION SYSTEM
- K040898 — CELLSEARCH EPITHELIAL CELL CONTROL KIT
- K041026 — AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
- K041308 — REMOTENURSE PATIENT MONITORING SYSTEM
- K041457 — LIQUICHEK HEMATOLOGY CONTROL (A)
- DEN040004 — CELLERATION MIST THERAPY SYSTEM
- K032948 — ELASTIC SKIN LIQUID BANDAGE
- K033776 — INSTEAD INTIMATE LUBRICANT
- K040241 — N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
- K040437 — TRIAGE PROFILER S.O.B. PANEL
- K040530 — MEDIA CULTURE SYSTEM
- K040687 — ONEDOSE PATIENT DOSIMETRY SYSTEM
- K040800 — WILOSN-COOK BILIARY DILATION BALLOON
- K040885 — QUANTA LITE GP210 ELISA
- K040908 — EBI DISTAL RADIUS PLATING SYSTEM
- K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT
- K041017 — SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
- K041077 — IMALUX OCT PROBE GUIDE
- K041191 — COLLEAGUE VOLUMETRIC INFUSION PUMPS
- K041332 — JOEY CLAMP OPENING TOOL
- K041398 — GC FUSION
- K041425 — CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
- K041440 — OPUS MAGNUM ANCHOR WITH INSERTER
- K041557 — MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
- K041577 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
- K031939 — BIO-EUROLIG INTERFERENCE SCREW
- K033303 — WAFER SYSTEM
- K033533 — POWDER FREE LATEX EXAMINATION GLOVES
- K034053 — TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040
- K040063 — INSPEKTOR PRO
- K040850 — TSY SHOULDER PLATE IMPLANT
- K041280 — HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
- K041370 — LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
- K041372 — SMARTLITE PS PEN-STYLE LED CURING LIGHT
- K041452 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K041597 — MONOCHROME LCD MONITOR, MODEL RADIFORCE G22
- K040316 — CEDIA BUPRENORPHINE ASSAY
- K040474 — ACCUSOFT
- K040494 — CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144
- K040953 — AESKULISA ANA HEP-2
- K041546 — DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
- K041590 — AUTODETECT SYRINGE
- K031368 — POWDERED LATEX SURGEON'S GLOVES
- K033464 — EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
- K040238 — SOFTSEAL HSG CATHETER
- K040817 — POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
- K040894 — QBTEST
- K040911 — VITALHEAT
- K041108 — ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
- K041369 — NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
- K041518 — CODMAN DURAFORM DURAL GRAFT IMPLANT
- K041521 — VOLUME VIEWER PLUS
- K041543 — GE DISCOVERY ST
- K041581 — COMPACS, VERSION 1.0
- K033868 — SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
- K040135 — THERMAGE THERMACOOL SYSTEM
- K040187 — MEDICINAL LEECHES
- K040413 — CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
- K040700 — CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037
- K040853 — PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
- K040950 — ALOCLAIR ORAL GEL
- K041500 — STARPACS ORTHOPEDICS SYSTEM
- K032836 — M3 MICROKERATOME
- K033785 — PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
- K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
- K040704 — MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
- K040728 — ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
- K040730 — VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
- K040777 — LCP RADIAL HEAD PLATING SYSTEM
- K040830 — PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
- K040874 — RED, WHITE & BLUE
- K040987 — CRYOCHECK CLOT C
- K041107 — TAIDOC CHECK
- K041303 — LED TURBO-PEN
- K041313 — STABIL-O-GRAPH
- K041412 — ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
- K041450 — MODIFICATION TO NICO WITH MARS, MODEL 7300
- K023956 — THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
- K030195 — BBP BONE SUBSTITUTES
- K040310 — NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS
- K040612 — SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
- K040721 — ASSURE ANTERIOR CERVICAL PLATE SYSTEM
- K040747 — ALADYN RIGID SPINE PLATE
- K040749 — MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
- K040755 — EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
- K040837 — MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
- K040847 — MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
- K040860 — INTEGRA BONE FIXATION SYSTEM
- K040864 — CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
- K041022 — NEUROQ - PET DP
- K041094 — HSG CATHETER SET
- K041165 — FSH MENOPAUSE PREDICTOR TEST
- K041200 — THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
Data sourced from openFDA. This site is unofficial and independent of the FDA.