FDA 510(k) clearances — page 643
clearances on record, most recent first.
Clearances — page 643
64,201–64,300 of 175,825- K051871 — STOMA BONE SCREW
- K052191 — MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
- K052262 — QUANTA LITE M2 EP (MIT3) ELISA
- K052558 — VCS, MODEL S4T
- K052685 — ORTHOPEDIC SALVAGE SYSTEM- OSS
- K052718 — V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
- K052721 — MINXRAY, MODEL HF100H+
- K052754 — WRIST FUSION PLATE
- K052783 — MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
- K052895 — FOURSIGHT VIEWTOOL IMAGE VIEWER
- K052904 — VIRTUAL MEDICAL SYSTEMS MODEL VT3000
- K050689 — SURGICAL FACE MASK
- K051089 — GII SPINAL FIXATION SYSTEM
- K051721 — GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
- K051727 — AIMSTICK URINE REAGENT STRIPS
- K052073 — FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
- K052346 — SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
- K052714 — RAVE COMPOSITE BRACKET
- K052849 — INFRARED THERMOMETER, FDIR-V1
- K052884 — MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
- K050394 — SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
- K050460 — GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
- K051452 — SENTINEL CLIN CHEM CAL
- K051587 — TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
- K051656 — OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
- K052000 — ARCHITECT CA 19-9XR ASSAY
- K052041 — COLLAGEN BONE HEALING PROTECTIVE SHEET
- K052416 — PERIPRO PATCH
- K052543 — HERACERAM ZIRKONIA
- K052859 — AQUAMANTYS PUMP GENERATOR SYSTEM
- K052893 — ATRICURE TRANSPOLAR SYSTEM
- K051214 — ALUMA SKIN RENEWAL SYSTEM
- K051548 — IRRADIA MID - LASER (S3)
- K052361 — SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
- K052563 — INOGEN SATELLITE CONSERVER, MODEL SC-100
- K043520 — EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR
- K051456 — SENTINEL CERULOPLASMIN
- K051579 — IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
- K051800 — IN6 SAFETY SYRINGE, MODEL 3ML
- K051812 — TGO SPRAY
- K051909 — DIAGNODENT
- K051948 — AVON PATELLO-FEMORAL JOINT PROSTHESIS
- K052061 — MODUS IMF SCREWS 2.0
- K052079 — PINNACLE CONSTRAINED ACETABULAR LINERS
- K052104 — ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION
- K052121 — GEM PREMIER 3000
- K052161 — POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
- K052178 — DEPUY CAS HIP INSTRUMENTATION
- K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
- K052292 — SPIDER CERVICAL PLATING (SCP) SYSTEM
- K052294 — SHOULDER NAIL PLATE
- K052349 — AVANTE LED CURING UNIT, MODEL N44
- K052501 — MULTIPLE RESIN TOOTH BONDING AGENT
- K052609 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K052631 — SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
- K052652 — SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
- K052734 — MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
- K052746 — CONCORDE VBR SPINAL SYSTEM
- K052857 — ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000
- K050192 — BRC SOFTWARE PRODUCT
- K050425 — AURA-PSG
- K051056 — VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
- K051562 — NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR
- K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001
- K051991 — POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE
- K051992 — POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM
- K052110 — M-SERIES PRO CPAP SYTEM
- K052155 — BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
- K052203 — AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
- K052409 — SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
- K052462 — G-COAT
- K052581 — LUNAR IDXA
- K052648 — MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
- K052707 — M3046B COMPACT PORTABLE PATIENT MONITORS
- K052717 — D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
- K052720 — MEDLINE IODOFORM PACKING STRIPS
- K052778 — THERMAGE THERMACOOL SKIN MARKETING
- K051501 — ZIRACE
- K052046 — BLOOD PRESSURE METER, MODEL CH-432
- K052103 — EXEL SECURE TOUCH II SAFETY SYRINGE
- K052173 — VITAGEL SURGICAL HEMOSTAT SPRAY SET
- K052240 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002
- K052514 — CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001
- K033405 — LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
- K051888 — TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
- K052040 — QUICKSMILE
- K052433 — PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
- K041704 — NEWGEL AND NEWGEL PLUS E
- K042352 — BIODERM SCIENCES WOUND CREAM
- K051531 — TECTONIC CERVICAL PLATE SYSTEM
- K051543 — ELECSYS PRECICONTROL BONE
- K051815 — MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
- K051976 — PROVEN REVISION MODULAR TIBIAL TRAY
- K052025 — URGENT PC NEUROMODULATION SYSTEM
- K052043 — 3.8MM CS FACET COMPRESSION DEVICE
- K052124 — ACTICLOT, MODEL 824
- K052175 — I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
- K052189 — REVENEER CERAMIC REPAIR SYSTEM
- K052284 — REFORMAT GATEWAY
- K052351 — HDR IORT SHIELDED APPLICATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.