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
106921–106944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1994
MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
K943737 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 15d
Cleared Aug 16, 1994
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
K932337 · JSM
Medical Packaging Corp.
Microbiology · 459d
Cleared Aug 16, 1994
SENSOR SHIELD, MODIFICATION
K933755 · DQA
Medical Taping Systems, Inc.
Anesthesiology · 468d
Cleared Aug 16, 1994
CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
K936078 · JSM
Medical Packaging Corp.
Microbiology · 326d
Cleared Aug 16, 1994
SUNGLASSES
K940969 · HQY
Tzong Rong Sunglasses Mfg. Co., Ltd.
Ophthalmic · 167d
Cleared Aug 16, 1994
UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
K941225 · DTZ
Baxter Healthcare Corp
Cardiovascular · 155d
Cleared Aug 16, 1994
CHECK VALVE SOLUTION SET
K941453 · FPA
Douglas Medical Products Corp.
General Hospital · 144d
Cleared Aug 16, 1994
AXSYM VALPROIC ACID
K941615 · LEG
Abbott Laboratories
Toxicology · 134d
Cleared Aug 16, 1994
TRANSTAR PRESSURE TRANSDUCER
K942377 · DPT
Medex, Inc.
Cardiovascular · 90d
Cleared Aug 16, 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · JLW
Abbott Laboratories
Chemistry · 77d
Cleared Aug 16, 1994
LIFE CLIP AND LIFE CLIP APPLIER
K943159 · FZP
Life Surgery, Inc.
General & Plastic Surgery · 46d
Cleared Aug 16, 1994
SUNGLASSES AND SPORT SUNGLASSES
K943501 · HQY
Sino-World Champion Co., Ltd.
Ophthalmic · 27d
Cleared Aug 15, 1994
REDINOV PERFUSION SET
K924010 · FPA
Bipress, Inc.
General Hospital · 735d
Cleared Aug 15, 1994
MODEL 118 FETAL/MATERNAL MONITOR
K934959 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 304d
Cleared Aug 15, 1994
TEFGEN-FD
K935137 · NPK
American Custom Medical, Inc.
Dental · 291d
Cleared Aug 15, 1994
FLEXTRANS
K935987 · JSM
Baxter Diagnostics, Inc.
Microbiology · 244d
Cleared Aug 15, 1994
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · BTT
Puritan Bennett Corp.
Anesthesiology · 243d
Cleared Aug 15, 1994
CASPAR TITANIUM ALLOY BONE SCREWS
K936269 · KWQ
Aesculap, Inc.
Orthopedic · 228d
Cleared Aug 15, 1994
3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)
K940446 · FRN
Minnesota Mining and Mfg. Co.
General Hospital · 195d
Cleared Aug 15, 1994
VISTA B12 ASSAY
K941235 · CDD
Syva Co.
Chemistry · 153d
Cleared Aug 15, 1994
SMARTSCAN
K941841 · GEX
Laserscope
General & Plastic Surgery · 124d
Cleared Aug 15, 1994
HEAT AND MOISTURE EXCHANGERS AND FILTERS
K941987 · BYD
Icor AB
Anesthesiology · 112d
Cleared Aug 15, 1994
CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR
K942597 · GCJ
Holmed Corp.
General & Plastic Surgery · 75d
Cleared Aug 15, 1994
KARL STORZ WOUND CLOSURE INSTRUMENTS
K942612 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 74d