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
86545–86568 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1999
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
K991079 · JXM
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN MTD, BIOSIGN MTD
K991080 · DJR
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA...
K991082 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
K991084 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 14, 1999
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851
K982134 · KDI
Dynamic Technology Corp.
Gastroenterology & Urology · 301d
Cleared Apr 14, 1999
MEGA 4
K982144 · INI
Mega Motion, Inc.
Physical Medicine · 301d
Cleared Apr 14, 1999
MEGA 3
K982145 · INI
Mega Motion, Inc.
Physical Medicine · 301d
Cleared Apr 14, 1999
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
K984213 · MDA
Capital Marketing Technologies, Inc.
General & Plastic Surgery · 141d
Cleared Apr 14, 1999
DUMEX IODOFORM PACKING STRIP
K990332 · FRO
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 70d
Cleared Apr 14, 1999
HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU
K990361 · MAI
Arthrex, Inc.
Orthopedic · 68d
Cleared Apr 14, 1999
SMITH & NEPHEW HANDPORT SYSTEM
K990414 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 63d
Cleared Apr 14, 1999
DERMACOOL
K990417 · GEX
Optomed Corp.
General & Plastic Surgery · 63d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 14, 1999
OXYCON LENS
K990895 · HQD
Concise Contact Lens Co.
Ophthalmic · 28d
Cleared Apr 14, 1999
MODIFICATION OF: EBI SPINELINK SYSTEM
K990999 · MAI
Electro-Biology, Inc.
Orthopedic · 20d
Cleared Apr 14, 1999
NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
K991150 · BZD
Nellcor Puritan Bennett France Dvpt.
Anesthesiology · 8d
Cleared Apr 13, 1999
UNI-FLEX RESIN
K983461 · EBI
Trans-Atlantic Dental
Dental · 194d
Cleared Apr 13, 1999
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT...
K983892 · JPA
Roche Diagnostics/Boehringer Mannheim...
Hematology · 161d
Cleared Apr 13, 1999
HOLTER 2000
K990170 · MLO
Zymed Medical Instrumentation
Cardiovascular · 84d
Cleared Apr 13, 1999
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT...
K990172 · GKZ
Coulter Corp.
Hematology · 84d
Cleared Apr 13, 1999
WILTEK HOT BIOPSY FORCEPS
K990231 · KGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Apr 13, 1999
BARRIER SURGICAL GOWNS
K990395 · FYA
Johnson & Johnson Medical, Div. of...
General Hospital · 63d
Cleared Apr 13, 1999
ONTRAK TESTCUP-ER M2K
K990418 · DKZ
Roche Diagnostics Corp.
Toxicology · 62d