FDA 510(k) clearances — page 419
clearances on record, most recent first.
Clearances — page 419
41,801–41,900 of 176,542- K123855 — WATER-FILLED TEETHER
- K123925 — MTM CLEAR ALIGNER IN-OFFICE
- K130184 — ZENOLUX
- K130481 — SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
- K130559 — MOBICATH BI-DIRECTIONAL GUIDING SHEATH
- K130634 — CORIN METAFIX HIP STEM
- K130911 — RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
- K130917 — HEALIX ADVANCE KNOTLESS BR ANCHOR
- K130984 — PROFEMUR RENAISSANCE CLASSIC HIP STEM
- K131019 — ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
- K131088 — PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K131156 — LANX SPINAL FIXATION SYSTEM
- K131209 — TERASON USMART3200T ULTRASOUND SYSTEM
- K131246 — CORONIS 3MP
- DEN130002 — TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
- K122978 — SANICLAVE 102, MODEL RS-SC-102
- K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
- K123937 — ATOM TRANSCAPSULE V-707
- K130115 — DISCOVERY MR750W 3.0T
- K130430 — IVAS 10MM AND 15MM BALLOON CATHETER
- K122625 — GETINGE 800HC- SERIES STEAM STERILIZER
- K123133 — BARLE TISSUE ADHESIVE
- K123662 — THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
- K130444 — H-30 HOLMIUM LASER SYSTEM
- K130524 — BREATHID HP SYSTEM
- K130538 — WINX SLEEP THERAPY SYSTEM
- K130551 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K130804 — UROMAX ULTRA BALLOON DILATATION CATHETER
- K131299 — ANYTHINK PACS WORKSTATION
- K122214 — TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
- K122519 — DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
- K122705 — HUMICARE D900
- K122735 — SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
- K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
- K123726 — COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
- K130077 — REMSTAR SE
- K130189 — XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
- K130539 — HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
- K130842 — ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
- K131093 — ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
- K131119 — SOLANAS POSTERIOR STABILIZATION SYSTEM
- K122804 — ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
- K123115 — ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
- K123306 — NORDIC TUMOREX
- K123428 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
- K130457 — 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
- K130943 — AIGIS RX R PM/ AIGIS RX R ICD
- K120671 — DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
- K120749 — HUMAN IGG CSF KIT
- K120750 — HUMAN IGM CSF KIT
- K121976 — AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
- K122417 — SCOPEVALET DISPOSABLE BIOPSY VALVE
- K122974 — TRYOUT-VPS HOLDING PASTE
- K123022 — NEODENT IMPLANT SYSTEM
- K123510 — MAGNETOM SKYRA
- K123603 — OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
- K123821 — AIO HD OTOSCOPE
- K124034 — MECTALIF ANTERIOR
- K124051 — THE VAULT SYSTEM
- K130037 — BREATHE CPAP SYSTEM
- K130105 — RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
- K130377 — KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
- K130451 — NEUROQ 3.6
- K130533 — SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
- K130558 — SOMNODENT HERBST; CLASSIC, FLEX
- K130647 — XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML
- K130885 — MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
- K130922 — ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
- K122124 — PORTABLE X-RAY SYSTEM
- K122614 — VINTAGE MP PRESS OVER
- K122644 — ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
- K123082 — MOBILECT VIEWER
- K123400 — AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
- K123736 — CRYSTALSERT DELIVERY SYSTEM
- K124040 — FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
- K130639 — ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
- K130909 — GATEWAY ADVANAGE Y-ADAPTER
- K130924 — BRUXZIR SHADED
- K131118 — 4D VIEW
- K131224 — SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
- K120615 — ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
- K122493 — GENESISPLUS
- K122777 — NBX - NON BRIDGING EXTERNAL FIXATOR HAND
- K123542 — PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
- K123586 — EASYRA CREATININE REAGENT
- K123617 — 3F PRO-PICC
- K123800 — WRIST AUTOMATIC BLOOD PRESSURE MONITOR
- K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
- K130366 — BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
- K130463 — UCP HOME DRUG SCREENING TEST; CARDS, CUPS
- K130734 — SAUFLON MULTIPURPOSE SOLUTION
- K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER
- K123077 — VASCULAR CLAMPS
- K123551 — ITCLAMP 50
- K123912 — KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
- K123985 — SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
- K124022 — SPEED SHIFT
- K130479 — ILIZAROV DRILL TIP WIRES
- K130729 — EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.