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
92137–92160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 29, 1997
OPUS S MODEL 4121 AND 4124 PACEMAKERS
K970072 · DXY
Ela Medical, Inc.
Cardiovascular · 233d
Cleared Aug 29, 1997
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K970296 · MCW
Boston Scientific Corp
Cardiovascular · 214d
Cleared Aug 29, 1997
MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
K970347 · DTE
Paladin Medical, Inc.
Cardiovascular · 214d
Cleared Aug 29, 1997
AMBIDERM
K971102 · LYY
Supertex Industrial, S.A. DE C.V.
General Hospital · 156d
Cleared Aug 29, 1997
W.A.
K971200 · LYY
W.A. Rubbermate Co., Ltd.
General Hospital · 150d
Cleared Aug 29, 1997
CRYO CHECK INR VALIDATION SET
K971219 · GGN
Precision Biologicals, Inc.
Hematology · 149d
Cleared Aug 29, 1997
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998 · GKL
Bayer Corp.
Hematology · 91d
Cleared Aug 29, 1997
SPOROX TEST STRIPS
K972035 · JOJ
Serim Research Corp.
General Hospital · 88d
Cleared Aug 29, 1997
MSI MAGNA-STYM
K972055 · IPF
Microvas Systems, Inc.
Physical Medicine · 88d