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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
163513–163536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1981
GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I
K810043 · GQM
Vibac Corp.
Microbiology · 128d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD, TINED #3262
K810396 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD-FLANGE #3260
K810397 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABLE PACING LEAD, MODEL 3266
K810398 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
APC IMPLANTABEL PACING LEAD, MODEL 3264
K810399 · DTB
American Pacemaker Corp.
Cardiovascular · 86d
Cleared May 15, 1981
MODELS 8420 THRU 8423 PACEMAKER GENER
K810734 · DXY
Medtronic Vascular
Cardiovascular · 58d
Cleared May 15, 1981
CORATOMIC MODEL OVALITH-920
K810808 · DXY
Coratomic, Inc.
Cardiovascular · 52d
Cleared May 15, 1981
FOGARTY FLEXIBLE CALIBRATOR
K810894 · DWP
American Edwards Laboratories
Cardiovascular · 42d
Cleared May 15, 1981
ANIS IRRIGATING SPATULA
K810937 · HND
American V. Mueller
Ophthalmic · 38d
Cleared May 15, 1981
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
K811011 · GIA
Sigma Chemical Co.
Toxicology · 30d
Cleared May 15, 1981
POSITIVE CLOSURE ANESTHETIC VALVE
K811015 · CAI
Orthopedic Systems, Inc.
Anesthesiology · 30d
Cleared May 15, 1981
ARIA II INSULIN RIA
K811144 · CFP
Bd Becton Dickinson Vacutainer...
Chemistry · 18d
Cleared May 15, 1981
URINE PREGNANCY TEST STANDARD/CONTR. PK
K811150 · JJX
Mallinckrodt Critical Care
Chemistry · 18d
Cleared May 15, 1981
COLLARLESS TOTAL HIP FEMORAL COMP. SYS
K811151 · JDI
Howmedica Corp.
Orthopedic · 18d
Cleared May 15, 1981
DADE RPR CARD TEST
K811152 · GMQ
American Dade
Microbiology · 18d
Cleared May 15, 1981
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
K811169 · JFH
Amersham Corp.
Chemistry · 17d
Cleared May 15, 1981
TIGGES SPINAL
K811176 · IPW
The Tiggs Co.
Physical Medicine · 17d
Cleared May 15, 1981
QUANTA PHASE VITAMIN B-12/FOLATE RAD
K811177 · CGN
Bio-Rad
Chemistry · 17d
Cleared May 15, 1981
HUMAN IGG-ALBUMIN TEST KIT
K811178 · CJQ
Meloy Laboratories, Inc.
Chemistry · 17d
Cleared May 15, 1981
OSMOMETER MODEL OM-6010
K811179 · JJM
Fiske Med Science
Chemistry · 17d
Cleared May 15, 1981
ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ
K811180 · HOS
American Optical Corp.
Ophthalmic · 17d
Cleared May 15, 1981
MULTIANALYTE CONTROLS, ALL KINDS
K811182 · JJY
Fisher Scientific Co., LLC
Chemistry · 17d
Cleared May 15, 1981
NORELCO BLOOD PRESSURE METER
K811188 · DXN
North American Philips Corp.
Cardiovascular · 16d
Cleared May 13, 1981
KEELER/KONAN SPECULAR MICROSCOPE
K810403 · HJO
Keeler Optical Products , Ltd.
Ophthalmic · 84d