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
164161–164184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1981
VISUAL PATTERN REVERSAL GEN. & PHOTIC S.
K810481 · GWE
Amplaid USA, Inc.
Neurology · 16d
Cleared Mar 11, 1981
FALLOPIAN TUBE FORCEPS
K810483 · KNA
American V. Mueller
Obstetrics & Gynecology · 16d
Cleared Mar 11, 1981
OVARY FORCEPS
K810484 · KNA
American V. Mueller
Obstetrics & Gynecology · 16d
Cleared Mar 11, 1981
BONE FIXACTION SCREW
K810497 · HWC
Serrano Intl.
Orthopedic · 15d
Cleared Mar 11, 1981
THERACHEM ANTI CONVULSANTA THEOPHYLLINE
K810504 · DIF
Fisher Scientific Co., LLC
Toxicology · 15d
Cleared Mar 11, 1981
CIRCLE NEPHROSTOMY TUBE INTRODUCER
K810533 · KOA
American V. Mueller
Gastroenterology & Urology · 13d
Cleared Mar 11, 1981
GEMENI QUICK-MB SEPARATION KIT
K810534 · JHT
Gemini, Inc.
Chemistry · 13d
Cleared Mar 11, 1981
AUTOMATIC SCREENING AUDIOMETER
K810537 · EWO
Positron
Ear, Nose, Throat · 13d
Cleared Mar 11, 1981
INCONTINENT PAD & BELT
K810544 · EYQ
Principle Business Ent.
Gastroenterology & Urology · 12d
Cleared Mar 11, 1981
BLSI VENTILATION MONITOR
K810547 · CAP
Bunnell Life Systems, Inc.
Anesthesiology · 9d
Cleared Mar 11, 1981
NEOCARE OXYGEN MONITOR
K810571 · CCL
Vickers America Medical Corp.
Anesthesiology · 8d
Cleared Mar 10, 1981
MBI-4
K810247 · IPF
Bloomex International, Inc.
Physical Medicine · 40d
Cleared Mar 09, 1981
ELA MEDICAL PACING LEAD MODEL PMA 860
K810626
Ela Medical, Inc.
Cardiovascular
Cleared Mar 06, 1981
COPPER SULFATE SOLUTION SP. GR.1.053
K803094 · KLS
Accra Laboratories, Inc.
Hematology · 88d
Cleared Mar 06, 1981
COPPER SULFATE SOLUTION SP. GR.1.055
K803095 · KSL
Accra Laboratories, Inc.
Hematology · 88d
Cleared Mar 06, 1981
SKIN BEAUTY CLEANSER & TONER
K803314 · IPF
Dynex International, Ltd.
Physical Medicine · 67d
Cleared Mar 06, 1981
DAC-CEL DIAGNATAL
K810214 · JHI
Burroughs Wellcome Co.
Chemistry · 38d
Cleared Mar 06, 1981
CONDYLAR KNEE W/METAL ENCAPSULATED TIB
K810230 · HRY
Hexcel Medical
Orthopedic · 38d
Cleared Mar 06, 1981
NORMLCERA
K810268 · KIS
Medical Specialties Laboratories
Chemistry · 32d
Cleared Mar 06, 1981
ACRYTOL, MOUNTING MEDIUM
K810323 · KEP
Surgipath
Pathology · 28d
Cleared Mar 06, 1981
PRE-VAP CAPS
K810394 · JJC
Sherman Boosalis
Chemistry · 16d
Cleared Mar 06, 1981
EMIT-ST SERUM BENZODIAZEPINE ASSAY
K810463 · JXM
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
EMIT-ST SERUM CALBRATOR
K810464 · DKB
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
EMIT-ST ETHYL ALCOHOL SERUM CONTROLS
K810465 · DKC
Syva Co.
Toxicology · 11d