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
81097–81120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 25, 2000
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
K994198 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 256d
Cleared Aug 24, 2000
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
K000158 · GEX
Fisma, Inc.
General & Plastic Surgery · 218d
Cleared Aug 24, 2000
VAPOTHERM, MODEL 2000I
K000401 · BTT
Vapotherm, Inc.
Anesthesiology · 199d
Cleared Aug 24, 2000
CHROMOSTREAK
K000718 · JSN
Novamed , Ltd.
Microbiology · 174d
Cleared Aug 24, 2000
ODONTOSURGE 3
K001560 · EKZ
Odonto-Wave
Dental · 97d
Cleared Aug 24, 2000
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 &...
K001633 · MSD
Vasca, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 24, 2000
C-REACTIVE PROTEIN ANTISERUM KIT
K001636 · DCK
The Binding Site, Ltd.
Immunology · 86d
Cleared Aug 24, 2000
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K001666 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 24, 2000
SYNTHES SACRAL BAR SYSTEM
K001720 · JDW
Synthes (Usa)
Orthopedic · 79d