FDA 510(k) clearances — page 575
clearances on record, most recent first.
Clearances — page 575
57,401–57,500 of 176,542- K080353 — LTM-T SURGICAL MESH
- K080789 — BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202
- K070584 — SMART-ROD
- K071517 — AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.
- K072551 — LD-I 75 AND LD-I 200
- K073445 — CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
- K073468 — MIMICS
- K073494 — CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
- K080191 — EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM
- K080376 — ONCOBIONIC SYSTEM
- K080444 — CONMED LINVATEC OSPREY DRILL SYSTEM
- K080557 — BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
- K080593 — FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
- K080622 — ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
- K080715 — ERBE VIO ESU, MODEL VIO 200 S
- K080753 — AESCULAP ENDOSCOPIC CLIP SYTEM
- K080784 — WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE
- K080820 — TEM 3002G- HN DUAL TUNE HEAD COIL
- K071626 — DUREX PLAY SOFT & SENSUAL LUBRICANT
- K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
- K073137 — GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
- K073434 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
- K080131 — VPAP ST
- K070310 — B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
- K073075 — FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
- K073706 — RESPIRATORY HUMIDIFIER, MODEL MR850
- K080271 — INREACH SYSTEM
- K080610 — ARTHROCARE ORTHOWAND SURGICAL DEVICE
- K080698 — GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
- K071489 — HOMECHECK MULTIPLE DRUG CUP TEST
- K072847 — APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
- K073278 — SPINOUS PROCESS PLATE SYSTEM
- K073519 — QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
- K073550 — PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
- K073673 — SOYALA FULL FACE MASK GEL VENTED
- K073713 — BLUE SKY BIO DENTAL IMPLANT SYSTEM
- K080402 — ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
- K061907 — MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
- K072185 — AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
- K072400 — NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
- K072403 — NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
- K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
- K073111 — PORTRAIT PSR, MODEL 745915
- K080228 — ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
- K080548 — HD7 DIAGNOSTIC ULTRASOUND SYSTEM
- K080717 — HABIB HEXABLATE 10
- K080758 — AVS PL PEEK SPACERS, MODELS 48351 AND 48353
- K063813 — VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
- K073262 — BELLA
- K073342 — SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
- K073583 — MODIFICATION TO PALOMAR LUX1540 HANDPIECE
- K073671 — PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
- K073699 — MCT-DIABETES
- K080104 — VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
- K080184 — DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
- K080203 — MTA ROOT CANAL SEALER
- K080264 — MODIFICATION TO: FOX PLUS PTA CATHETER
- K080514 — PECD-01 AND PECD QUICK-01
- K071254 — SMALL INTESTINAL VIDEOSCOPE SYSTEM
- K072321 — BIOFLEX
- K072329 — SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
- K072441 — EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K073455 — E-VAC
- K080101 — AAP CANNULATED SCREW AND DARCO HEADED SCREW
- K080170 — AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
- K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
- K070184 — DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT
- K073255 — XPS 3000 SYSTEM
- K073502 — VERTEBRON VBR SYSTEM
- K073674 — BONE FIXATION WIRE (KIRSCHNER WIRE)
- K073705 — MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE
- K080157 — DASH 2500 PATIENT MONITOR
- K080302 — CAYMAN BUTTRESS PLATE SYSTEM
- K080495 — SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
- K080661 — MODELS TENS 7000, EMS 7500 AND TWIN STIM
- K063684 — COBAS LITHIUM
- K072369 — EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
- K072406 — NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
- K072739 — JIERUI SYRINGES AND NEEDLES
- K073346 — ZIEHM VISION 2
- K073391 — SURGISIS BIODESIGN TISSUE GRAFT
- K080051 — VIRTUAL PORTS ENDOCLEAR SYSTEM
- K080508 — MANDREL GUIDEWIRES OR M-WIRE
- K080640 — M5 DIAGNOSTIC ULTRASOUND SYSTEM
- K080680 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
- K070855 — SLEEP QUALITY
- K071468 — CLARIVEIN CATHETER
- K071694 — COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX
- K072116 — SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM
- K072411 — AAP BONE PLATES AND SCREW IMPLANTS
- K072723 — RESPIRONICS GOLOX
- K073227 — SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
- K073240 — PSS SYSTEM
- K073363 — THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300
- K073624 — MODULAR FOOT SYSTEM
- K073637 — PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
- K073638 — SWIFT LT
- K073652 — ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE
- K073653 — SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
- K080109 — SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.