FDA 510(k) clearances — page 680
clearances on record, most recent first.
Clearances — page 680
67,901–68,000 of 175,825- K041627 — CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR
- K041777 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K041844 — ALL SAFE HUBER SAFETY INFUSION SETS
- K041853 — OTOGRAM
- K042008 — ULTRAVISUAL
- K042301 — PROTENS ELECTRODE
- K031788 — PATHFINDER
- K033132 — STRYKER SWITCHPOINT INFINITY
- K040812 — DETECT SURGICAL PACING AND MAPPING TOOL
- K040831 — DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
- K040858 — ORALIEF THERAPY FOR SENSITIVE TEETH
- K040903 — CADENCE, MODELS 2001 AND 2002
- K041405 — ASPIRATION PUMP, MODEL IMD-020
- K041638 — TARGETSCAN BIOPSY KIT
- K041639 — TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
- K041647 — FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
- K041979 — MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
- K042088 — SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
- K042187 — ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
- K042192 — LOW FLOW OSV II HYDROCEPHALUS VALVE
- K042247 — SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
- K031370 — SHINMED MODE SW-988 UNTRASONIC NEBULIZER
- K033491 — ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS
- K041502 — THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
- K041533 — SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
- K041549 — ZIMMER TRABECULAR METAL HUMERAL STEM
- K041637 — TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
- K041705 — RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
- K042003 — INFINITY TRIDENT NMT POD
- K042010 — POWER SCOOTER, MODEL TL-688
- K042094 — R&D CBC-XE HEMATOLOGY CONTROL
- K042182 — Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
- K042229 — SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
- K032831 — PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200
- K040380 — DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
- K040562 — LIFECLINIC, MODEL 2400
- K041034 — SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)
- K041089 — OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
- K041379 — PRE-POWDERED VINYL EXAM GLOVES
- K041778 — REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T
- K041900 — HC604 CPAP HUMIDIFIER
- K041901 — SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER
- K042086 — FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
- K042154 — GE DATEX-OHMEDA AISYS CARESTATION
- K042218 — ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
- K042246 — MULTI-DRIP INFUSION CATHETER
- K042265 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
- K042266 — ACCLAIM
- K042273 — MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
- K032910 — CARRIAZO PENDULAR
- K041120 — EV APAN DIGITAL, MODEL K1VSM2000
- K041657 — THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
- K041685 — ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
- K041960 — COMPOSITE/COMPOMER REPAIR KIT
- K042178 — ORTHODONTIC CERAMIC BRACKETS
- K042245 — VAPOTHERM MODEL#2000I, 200H
- K031502 — USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
- K040315 — MYOHEALTH CLENCHING INHIBITOR
- K040928 — EXPANDABLE PEEK VBR IMPLANT
- K040947 — DURASUL BIPOLAR
- K041333 — SYNTHES (USA) TITANIUM WIRE
- K041428 — ACCUSOL DIALYSIS SOLUTION
- K041508 — BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM
- K041563 — OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
- K041601 — SURFIX KNEE OSTEOTOMY SYSTEM
- K041683 — B. BRAUN BICARBONATE DIALYSATE
- K041997 — RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
- K042005 — ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
- K042045 — NXSTAGE PUREFLOW-B SOLUTION
- K042078 — ENDOTINE FOREHEAD TRIPLE DEVICE
- K042101 — CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES
- K042126 — PICC
- K042150 — XLTEK TREX MODEL#10309
- K042177 — MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
- K032971 — TIDAL WAVE SP MODEL 710/715 AND 715
- K040476 — STORZ MODULITH, MODEL SLX-F2
- K040580 — AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
- K040703 — URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
- K041123 — RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
- K041419 — LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
- K041421 — NAME BONE VOID FILLER
- K041509 — ANKYLOS DENTAL IMPLANT SYSTEM
- K041585 — AUTOFUSER AMBULATORY INFUSION PUMP
- K041661 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS
- K041711 — ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
- K041846 — SABRESOURCE DRAPE
- K041929 — MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
- K041931 — OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
- K042017 — BAHA DIVINO
- K042053 — INNOVA 4100, INNOVA 3100
- K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
- K042121 — SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
- K042186 — 3.0T 8-CHANNEL CTL SPINE ARRAY
- K042207 — 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
- K033122 — 5000Z SYSTEM (OTC)
- K040191 — BICONTACT HIP STEM AND FEMORAL HEAD
- K040734 — MODIFICATION TO RESTORATION MODULAR SYSTEM
- K041451 — ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
- K041456 — SNAP-OFF SCREWS
- K041573 — NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
Data sourced from openFDA. This site is unofficial and independent of the FDA.