FDA 510(k) clearances — page 664
clearances on record, most recent first.
Clearances — page 664
66,301–66,400 of 175,825- K050297 — SOMATOM EMOTION 16
- K050360 — TULIP CONDOM
- K032410 — SNORENTI
- K041884 — MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
- K043242 — TRIAGE TOX DRUG SCREEN
- K043425 — SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)
- K043457 — MODIFICATION TO ENDOVASCULAR GUIDE WIRE
- K043461 — CUSTODIOL
- K050075 — VITEK 2 GRAM POSITIVE DAPTOMYCIN
- K050089 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML
- K050200 — MAGNETOM TRIO A TIM SYSTEM
- K050253 — USGI SHAPELOCK ENDOSCOPIC GUIDE
- K050298 — IPACS PRISM-5.0
- K050307 — AIRIS ELITE RAPID BODY COIL
- K050326 — 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
- K041908 — CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
- K042110 — BEAMCATH
- K042813 — BIOBEAM NARROW BAND LIGHT THERAPY DEVICES
- K043010 — HOLTER RECORDER H3+
- K043170 — BOSWORTH BOND
- K043284 — ENDOASSIST
- K043507 — ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE
- K043599 — MOMENTS MENOPAUSE CHECK, MODEL 9113
- K050004 — PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
- K050041 — SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
- K050100 — RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
- K050176 — VORTEX EZ VASCULAR ACCESS PORT
- K050303 — 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
- K050308 — THERMAL CAUTERY PROBE
- K050339 — SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
- K050347 — MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
- K041885 — BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS
- K043104 — KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
- K043255 — ELLIPSE LIGHT SPT
- K043410 — EPIPHYSIS SCREW
- K043575 — DERMILLUME, MODEL PRO1000
- K050196 — SECTRA IDS5 WORKSTATION
- K050223 — VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER
- K050299 — HRK-123 KNEE ARRAY COIL
- K050313 — BIS SRS (SEMI-RESUABLE SENSOR)
- K050317 — BURANE XL
- K040905 — WELLNESS/JOLIVETE
- K042054 — SILIMED PECTORAL IMPLANT
- K042563 — DUREX PLAY WARMER LUBRICANT
- K043297 — MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
- K043602 — QUADRANT RETRACTOR SYSTEM
- K050380 — XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
- K050386 — PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
- K031660 — FERRIS POLYMEM STERILE BREAST PAD
- K042274 — PSD-60/ENDOPLASMA
- K042500 — DUOPROSS SYRINGES
- K042768 — MEDICOMPASS CONNECT
- K043074 — LIBERTY SYSTEM
- K043444 — MULTIPLE, MODEL KTJ-50
- K043572 — COMPATIBILITY ECG TRUNK CABLES
- K050159 — MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
- K050191 — MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
- K031399 — INTERGRO DBM
- K042600 — STANSION MATRIX
- K042683 — WELL LEAD ENDOTRACHEAL TUBE
- K042904 — INFINITY KAPPA XLT
- K042984 — INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
- K043054 — GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
- K043142 — INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
- K043145 — BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
- K043160 — TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
- K043338 — BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
- K043351 — 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N
- K043439 — INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL
- K043440 — SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
- K043490 — PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
- K043551 — DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES
- K043553 — SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
- K050023 — SECURELOC; ADVANCINTRODUCER
- K050076 — VITEK 2 GRAM POSITIVE ERTAPENEM
- K050078 — ROC LUMBAR PLATING SYSTEM
- K050133 — D-STAT RADIAL HEMOSTATIC BAND
- K050187 — PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
- K050199 — MAGNETOM SYMPHONY A TIM SYSTEM
- K050228 — AGFA HEARTLAB CARDIOVASCULAR
- K050282 — MODIFICATION TO TSRH SPINAL SYSTEM
- K050290 — LERADO, COSCO
- K050314 — AQUINOX
- K042308 — SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019
- K042553 — BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
- K042684 — WELL LEAD TRACHEOSTOMY TUBE
- K042928 — MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
- K042957 — DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
- K043100 — BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
- K043379 — SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
- K043411 — RESOFIX BIOABSORBABLE EXPANSION BOLT
- K043545 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
- K050002 — VITEK 2 COMPACT
- K050117 — MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
- K050363 — FUKUDA DENSHI MODEL UF-850XTD
- K033696 — PERSONAL INJECTOR
- K042360 — VARIAN NASOPHARYNX APPLICATOR
- K043199 — SURGICAL FACE MASK
- K043248 — TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS
Data sourced from openFDA. This site is unofficial and independent of the FDA.