FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
69553–69576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519 · HRS
Biomet, Inc.
Orthopedic · 28d
Cleared Dec 05, 2003
BLUEPHASE
K033520 · EBZ
Ivoclar Vivadent, Inc.
Dental · 28d
Cleared Dec 05, 2003
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
K033542 · DQX
Galt Medical Corp.
Cardiovascular · 25d
Cleared Dec 05, 2003
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · LBS
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Dec 04, 2003
CLC2000 CATHETER PATENCY DEVICE
K021692 · FPA
Icu Medical, Inc.
General Hospital · 561d
Cleared Dec 04, 2003
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT,...
K023023 · MSD
Vasca, Inc.
Gastroenterology & Urology · 449d
Cleared Dec 04, 2003
RANDOX RX DAYTONA
K024014 · CGA
Randox Laboratories, Ltd.
Chemistry · 365d
Cleared Dec 04, 2003
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
K031124 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 240d
Cleared Dec 04, 2003
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · HKX
Nidek, Inc.
Ophthalmic · 183d
Cleared Dec 04, 2003
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
K032309 · LRX
Novelens, Inc.
Ophthalmic · 132d
Cleared Dec 04, 2003
UP-GRADE FOREHEAD THERMOMETER
K032362 · FLL
Medisim, Ltd.
General Hospital · 126d
Cleared Dec 04, 2003
DEPUY ASR RESURFACING FEMORAL HEADS
K032659 · KXA
DePuy Orthopaedics, Inc.
Orthopedic · 98d
Cleared Dec 04, 2003
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
K032756 · EIA
A-Dec, Inc.
Dental · 90d
Cleared Dec 04, 2003
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED...
K032900 · DSY
Edwards Lifesciences, LLC
Cardiovascular · 78d
Cleared Dec 04, 2003
MIRAGE ACTIVA MASK
K032916 · BZD
Resmed, Ltd.
Anesthesiology · 73d
Cleared Dec 04, 2003
VISION-TECH YZ SLIT LAMP, MODEL 66
K033190 · HJO
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 64d
Cleared Dec 04, 2003
SENO ADVANTAGE
K033400 · LLZ
Ge Medical Systems W-400
Radiology · 41d
Cleared Dec 04, 2003
LAMITRODE SPINAL CORD STIMULATION LEADS
K033429 · GZB
Advanced Neuromodulation Systems
Neurology · 37d
Cleared Dec 04, 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE,...
K033576 · FPA
Abbott Laboratories
General Hospital · 21d
Cleared Dec 04, 2003
BOBCAT PRO SCALER SYSTEM, MODEL G-130
K033705 · ELC
Dentsply International
Dental · 9d
Cleared Dec 03, 2003
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
K024027 · ILY
Skytech Enterprises, Inc.
Physical Medicine · 362d
Cleared Dec 03, 2003
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
K030485 · MQN
Newmedical Technology, Inc.
Dental · 292d
Cleared Dec 03, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030834 · GEX
Candela Corp.
General & Plastic Surgery · 261d
Cleared Dec 03, 2003
ASEPTICO ENDOPEX V, MODEL AEU-40
K030895 · LQY
Aseptico, Inc.
Dental · 257d