FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81601–81624 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2000
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · IPF
Rich-Mar Corp.
Physical Medicine · 165d
Cleared Aug 25, 2000
NLITE SYSTEM, SLS MODEL NUMBER A00-1025
K000811 · GEX
Sls Biophile , Ltd.
General & Plastic Surgery · 165d
Cleared Aug 25, 2000
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
K001681 · KPS
Smv America
Radiology · 85d
Cleared Aug 25, 2000
ULTIMA SMARTBELT, MODEL 0560
K001743 · BZQ
Braebon Medical Corp.
Anesthesiology · 78d
Cleared Aug 25, 2000
PLAINSENSE WHEELCHAIR
K001909 · IOR
Plainsense Wheelchairs, Inc.
Physical Medicine · 64d
Cleared Aug 25, 2000
REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800
K001923 · ITI
Gendron, Inc.
Physical Medicine · 63d
Cleared Aug 25, 2000
TITAN POROCOAT HIP PROSTHESIS
K001991 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 57d
Cleared Aug 25, 2000
LACTOSORB MENISCAL SCREW
K002020 · MAI
Biomet Manufacturing, Inc.
Orthopedic · 53d
Cleared Aug 25, 2000
BIOLOK SCREW
K002070 · HWC
Biocomposites, Ltd.
Orthopedic · 49d
Cleared Aug 25, 2000
XIMX SYSTEM
K002100 · LLZ
Medical Manager Research Development
Radiology · 45d
Cleared Aug 25, 2000
FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN
K002129 · MGQ
Ferris Mfg. Corp.
General & Plastic Surgery · 42d
Cleared Aug 25, 2000
RANGER II M6, MODEL IN-888WNL
K002157 · ITI
Invacare Corp.
Physical Medicine · 39d
Cleared Aug 25, 2000
KARMAN WHEELCHAIR
K002167 · IOR
Karman Healthcare, Inc.
Physical Medicine · 38d
Cleared Aug 25, 2000
CAPELLA
K002200 · EWO
Madsen Electronics, Inc.
Ear, Nose, Throat · 36d
Cleared Aug 25, 2000
KARMAN WHEELCHAIR
K002202 · IOR
Karman Healthcare, Inc.
Physical Medicine · 36d
Cleared Aug 25, 2000
SPINA SYSTEM
K002260 · ITH
North American Medical Corporation (Nam)
Physical Medicine · 31d
Cleared Aug 25, 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271 · HWC
Synthes (Usa)
Orthopedic · 30d
Cleared Aug 25, 2000
FRESENIUS OPTIFLUX 200NR
K002277 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Aug 25, 2000
WIZAIR COMPRESSION SYSTEM
K002287 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 29d
Cleared Aug 25, 2000
MODEL 9000 BARIATRIC WHEELCHAIR
K002317 · IOR
Invacare Corp.
Physical Medicine · 25d
Cleared Aug 25, 2000
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
K002365 · DYB
Datascope Corp.
Cardiovascular · 22d
Cleared Aug 25, 2000
EHC500 DESKTOP PATIENT STATION, MODEL EHC500
K002388 · DXN
Cybercare, Inc.
Cardiovascular · 21d
Cleared Aug 25, 2000
COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS
K002491 · IYN
Medison Co., Ltd.
Radiology · 11d
Cleared Aug 25, 2000
AERONEB II, MODEL APN 200
K992831 · CAF
Aerogen, Inc.
Anesthesiology · 368d