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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69313–69336 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2003
POTENS +
K033137 · JPA
Wada, Inc.
Hematology · 69d
Cleared Dec 08, 2003
GYNECARE TVT OBTURATOR SYSTEM
K033568 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 26d
Cleared Dec 08, 2003
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K033613 · DTA
Biotronik, Inc.
Cardiovascular · 21d
Cleared Dec 05, 2003
MIDA ALGORITHM REV. B
K023414 · DYC
Ortivus AB
Cardiovascular · 420d
Cleared Dec 05, 2003
VPT METER
K030829 · LLN
Xilas Medical, Inc.
Neurology · 266d
Cleared Dec 05, 2003
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
K031649 · CBF
Fink Engineering Pty, Ltd.
Anesthesiology · 191d
Cleared Dec 05, 2003
IMMUNOCARDSTAT HPSA
K032222 · LYR
Meridian Bioscience, Inc.
Microbiology · 137d
Cleared Dec 05, 2003
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B),...
K032810 · KRH
Medtronic Heart Valves
Cardiovascular · 87d
Cleared Dec 05, 2003
HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
K032821 · NPP
Hygia Health Services, Inc.
Cardiovascular · 91d
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