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
92641–92664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1997
UNICAP PHADIATOP
K972364 · DHB
Pharmacia, Inc.
Immunology · 71d
Cleared Sep 04, 1997
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
K972367 · KIJ
Stryker Instruments
Orthopedic · 71d
Cleared Sep 04, 1997
RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000
K972441 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 66d
Cleared Sep 04, 1997
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516 · JDS
Synthes (Usa)
Orthopedic · 59d
Cleared Sep 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB...
K973030 · JJY
Johnson & Johnson Clinical...
Chemistry · 21d
Cleared Sep 04, 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K973222 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 14d
Cleared Sep 03, 1997
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
K964908 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 268d
Cleared Sep 03, 1997
CLINIJEL
K970581 · HIS
Hospicon Products
Obstetrics & Gynecology · 201d
Cleared Sep 03, 1997
FACE MASK, SURGICAL MASK, NON-STERILE
K970835 · FXX
Tucker & Associates
General Hospital · 196d
Cleared Sep 03, 1997
ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
K971132 · HIS
G. Premjee (Usa), Inc.
Obstetrics & Gynecology · 160d
Cleared Sep 03, 1997
VIEW ARCHIVING STATION
K971176 · IZI
Electromed Intl., Ltd.
Radiology · 156d
Cleared Sep 03, 1997
FLY THROUGH
K971717 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 117d
Cleared Sep 03, 1997
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION...
K972139 · BTM
Davis & Geck, Inc.
Anesthesiology · 89d
Cleared Sep 02, 1997
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
K971458 · JIQ
Diagnostic Specialties
Chemistry · 133d
Cleared Sep 02, 1997
PHILIPS EASYVISION
K972103 · LLZ
Philips Medical Systems North...
Radiology · 90d
Cleared Sep 02, 1997
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
K972113 · DSP
Boston Scientific Corp
Cardiovascular · 89d
Cleared Sep 02, 1997
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
K972556 · LAF
Phamatech
Toxicology · 55d
Cleared Sep 02, 1997
SMART SET
K972663 · FPA
Top Spins, Inc.
General Hospital · 56d
Cleared Sep 02, 1997
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720 · CGJ
Monobind
Chemistry · 43d
Cleared Sep 02, 1997
ARRIPRO 35 ST/TV
K973115 · IXC
Arnold & Richter Cine Technik
Radiology · 13d
Cleared Aug 29, 1997
LIFETECH CASSETTE
K960756 · KPJ
Lifetech Systems, Inc.
General & Plastic Surgery · 553d
Cleared Aug 29, 1997
BRONCHIAL BLOCKER
K962167 · CBI
Cook, Inc.
Anesthesiology · 450d
Cleared Aug 29, 1997
ARTOCOOL-S WATER CIRCULATING COLD PACK
K964354 · ILO
Ormed GmbH
Physical Medicine · 302d
Cleared Aug 29, 1997
ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
K964799 · ILO
Ormed GmbH
Physical Medicine · 273d