FDA 510(k) clearances — page 756
clearances on record, most recent first.
Clearances — page 756
75,501–75,600 of 175,825- K021958 — TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H
- K010065 — CRANIAL STEREOTACTIC EQUIPMENT
- K013205 — MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
- K013689 — RE-ENTRANT CHAMBER
- K014208 — SSIR SYSTEM
- K014255 — DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400
- K020021 — LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
- K020386 — INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
- K020399 — RESPERATE; MODEL RR-150
- K021124 — ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
- K021146 — D/SENSE 1-STEP
- K021180 — CANDELA VBEAM PULSED DYE LASER SYSTEM
- K021314 — SCEPTRE-VS
- K021318 — XIVE DENTAL IMPLANT SYSTEM
- K021346 — STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
- K021417 — AART CHIN IMPLANT
- K021418 — AART NASAL IMPLANT
- K021419 — AART MALAR IMPLANT
- K021521 — STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
- K021534 — IQ NASAL MASK, MODEL 50160 REV. D
- K021566 — INFINITI
- K021824 — DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
- K021829 — MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
- K021830 — SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
- K021911 — TRIDENT CROSSFIRE POLYUETHYLENE LINERS
- K021941 — SAMPLOK LUER KIT
- K021961 — POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
- K021966 — Q LAB SOFTWARE
- K021984 — PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT
- K022020 — JUSTWO MODEL TME-601 ROOT APEX LOCATOR
- K011037 — VERTEBRAL SPACER
- K011220 — LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE
- K013061 — BIOTOUCH MASSAGE THERAPY SYSTEM
- K013182 — TRIPLE LUMEN CENTRAL VENOUS CATHETER
- K020486 — CARESIDE GGT
- K020714 — RUSCH FLONEIL; FLOCATH INTROGEL
- K021063 — GREAT TOE IMPLANT
- K021071 — PCCS GRAFT DELIVERY SYSTEM
- K021079 — ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX
- K021164 — MACROPORE OS TRAUMA
- K021165 — NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
- K021196 — NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
- K021221 — O&P CRANICAL MOLDING HELMET
- K021317 — TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
- K021349 — METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
- K021825 — MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
- K021828 — SMALL HAMMER TOE PIN
- K021831 — OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
- K021869 — OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
- K021883 — BIOFASTIN RC THREADED SUTURE ANCHOR
- K021895 — BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
- K002159 — SNORE SAT RECORDER, MODEL SS41
- K020211 — BODY FORCE, MODEL BT 6000
- K020382 — BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
- K020932 — DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
- K021097 — QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
- K021140 — FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
- K021229 — MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
- K021290 — VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100
- K021305 — MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER
- K021345 — MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
- K021754 — APEX MEDICAL DIGITAL EMS TS1311, TS1312
- K021943 — ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
- K003720 — ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
- K012669 — REPROCESSED ELECTROSURGICAL ELECTRODES
- K013613 — SOFT PLUG ABSORBABLE PLUG-SA
- K020979 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
- K021099 — REX, VERSION 1.0
- K021141 — MILLENNIUM 5000 MEUROVASCULAR COIL
- K021288 — ORS-1000LD
- K021373 — H12+HOLTER RECORDER
- K021480 — EXTENSION SET LIGHT-SAFE, MODEL BC565
- K021532 — ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
- K021535 — ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
- K021607 — RDI HS CRP CALIBRATOR SET
- K021609 — RDI HS CRP KIT
- K021756 — WELCH ALLYN ABPM 6100
- K021797 — L.E.DEMETRON
- K021801 — BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
- K012308 — KAVO QUATTROCARE
- K014114 — GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
- K014281 — GARD FILTER, COMBIGARD FILTE / HME
- K014282 — BACSTOP FILTER,BACSTOP FILTER/HME
- K020056 — DUET SUTURE ANCHOR
- K020974 — BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
- K021034 — MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
- K021036 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
- K021045 — ERA IMPLANT
- K021050 — KSEA NEUROENDOSCOPES AND ACCESSORIES
- K021137 — SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM
- K021168 — JUMP START, MODEL 970300
- K021211 — MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM
- K021223 — BELIMED STEAM STERILIZER, MODEL TOP 5000
- K021227 — SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
- K021289 — WARMER 2000LD
- K021299 — CONMED HEATWAVE HAND-CONTROLLED ELETRODE
- K021684 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K021733 — AUTOPAL 50
- K021741 — CRITERTION, MODEL #1067511
- K021744 — T2 FEMORAL NAIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.