FDA 510(k) clearances — page 851
clearances on record, most recent first.
Clearances — page 851
85,001–85,100 of 176,637- K994388 — XE CHECK
- K994439 — ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
- K990987 — BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
- K991862 — MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
- K992053 — AESCULAP VASCULAR INSTRUMENTS
- K992434 — ITP, MODEL 1.0
- K992454 — VENAFLOW SYSTEM, MODEL 30A
- K992584 — PE 501 PC-ECG MONITOR
- K992729 — NIPRO LUER ADAPTOR
- K992779 — A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
- K993377 — MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
- K993531 — PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
- K993550 — AVIVA SYSTEM, MODEL SL1010
- K993551 — SOCON SPINAL SYSTEM
- K993657 — ACUMED SUTURE ANCHOR
- K993963 — SIGMA MANUAL WHEELCHAIR
- K994048 — PORTABLE LIGHT CURING UNIT
- K994072 — AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM
- K994107 — AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
- K994185 — MANUAL WHEELCHAIR
- K994208 — AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
- K994241 — TRX-CG POWER TILT AND RECLINE SYSTEM
- K994313 — MODIFICATION TO BONE ANCHOR AND KIT (BAK)
- K994358 — ATW MARKER WIRE STEERABLE GUIDEWIRE
- K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR
- K992116 — SIEMEMNS INFINITY ETC02 POD
- K992258 — HOT SHOT FLUID WARMER IV FLUIDS
- K992396 — BIORCI SCREW
- K992719 — AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
- K992941 — LEMAITRE BILIARY CATHETER
- K993472 — SEGMENTED VAGINAL APPLICATOR
- K993567 — INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
- K993793 — GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
- K993795 — CONVERTORS SURGICAL DRAPES
- K993839 — ENA PROFILE ELISA TEST SYSTEM
- K993859 — SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
- K993880 — SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K994028 — FLIPO XENON CURING LIGHT
- K994056 — ADMIRA
- K994325 — SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
- DEN000001 — OHMEDA INOVENT DELIVERY SYSTEM
- K971732 — DENTAL HANDPIECE
- K990856 — HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
- K992256 — FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
- K992489 — 3M TR SYSTEM
- K992916 — BRAINLAB STEREOTACTIC ARC
- K992959 — BEHRING COAGULATION SYSTEM (BCS)
- K993455 — FLIPPER DETACHABLE EMBOLIZATION COIL
- K993460 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
- K993465 — DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
- K993526 — SYNEA - LS LOW-SPEED HANDPIECE
- K993664 — SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
- K993843 — MDI RF TEST
- K993954 — SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
- K993971 — MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
- K993973 — FUJI II LC CAPSULE
- K994029 — MDI SM TEST
- K994037 — THE 4.5MM DIAMETER BICON DENTAL IMPLANT
- K994043 — CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
- K991391 — PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
- K991962 — EIS DYNAMIC MEMORY STAPLES SYSTEM
- K992016 — AMUKIN D
- K992744 — MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
- K992767 — BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
- K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
- K992998 — AUTOMATED OPHTHALMICS SOFTIPS
- K993151 — RADID DRUG SCREEN 5-PANEL TEST
- K993411 — FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
- K993522 — AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
- K993560 — FRIALIT-2 BONE PROFILER
- K993635 — MDI SM/RNP TEST
- K993636 — MDI SS-A TEST
- K993789 — CLINICAL BLOOD GAS MIXTURE
- K993897 — CERGOGOLD
- K994051 — HARDYDISK DOXYCYCLINE, 30MCG
- K994269 — TITAN RC TACK
- K990962 — FLOSENSE, MODEL 29-8010
- K992285 — SALTER AIRE COMPRESSOR
- K992455 — NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
- K992911 — MAGSTIM RAPID
- K993039 — VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
- K993426 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
- K993429 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40
- K993493 — THE AUTOTAC SYSTEM
- K994156 — MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
- K994272 — AUTOMATED CORE BIOPSY DEVICE
- K994326 — ASCENT KNEE SYSTEM
- K983866 — BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
- K990803 — MEDISYSTEMS BUTTONHOLE NEEDLE SETS
- K991959 — PSI TITANIUM ANEURYSM CLIP
- K992101 — CRITERION 40 OR PM 40
- K993392 — BARD MEMOTHERM FLEXX BILIARY STENT
- K993400 — HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
- K993738 — DISPOS-A-SCOPE
- K993778 — HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
- K993892 — DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
- K993948 — SIS WOUND DRESSING II
- K993210 — ACCESS HYBRITECH FREE PSA QC, MODEL 37219
- K993376 — ENSTYLET MODELS EC0010, EC0020
- K993407 — OHMEDA MEDICAL OMNIBED
Data sourced from openFDA. This site is unofficial and independent of the FDA.