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
159169–159192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1982
LARYNGEAL MIRRORS
K822261 · KAI
Kelleher Corp.
Ear, Nose, Throat · 32d
Cleared Aug 30, 1982
ENT CURRETTES
K822273 · JYG
Kelleher Corp.
Ear, Nose, Throat · 32d
Cleared Aug 30, 1982
MYLE'S GUILLOTINE
K822274 · KBO
Kelleher Corp.
Ear, Nose, Throat · 32d
Cleared Aug 30, 1982
ENT KNIFE HANDLES
K822280 · KTG
Kelleher Corp.
Ear, Nose, Throat · 32d
Cleared Aug 30, 1982
FIBEROPTIC LIGHT CARRIERS
K822282 · EQH
Kelleher Corp.
Ear, Nose, Throat · 32d
Cleared Aug 30, 1982
REINFORCING PIN
K822412 · EBL
Filhol
Dental · 20d
Cleared Aug 30, 1982
TRACOR RA400 AUDIOMETER
K822414 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 19d
Cleared Aug 30, 1982
NEW CROWN AND BRIDGE ALLOY NO. DW196
K822419 · EJS
Williams Gold Refining Co., Inc.
Dental · 19d
Cleared Aug 30, 1982
GARDS (UNSCENTED, MENSTRUAL PAD)
K822433 · HHD
Hospital Specialty Co.
Obstetrics & Gynecology · 18d
Cleared Aug 30, 1982
HPF 100,200,300 CAPILLARY FLOW DIALYZ
K822485 · FKQ
Erika, Inc.
Gastroenterology & Urology · 13d
Cleared Aug 27, 1982
NU-GAUZE SPONGE
K821150 · EFQ
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 126d
Cleared Aug 27, 1982
RHEUMATOID FACTOR REFERENCE PREPARA.
K821941 · DHR
Armkel, LLC
Immunology · 59d
Cleared Aug 27, 1982
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949 · DAK
Ortho Diagnostic Systems, Inc.
Immunology · 58d
Cleared Aug 27, 1982
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
K821975 · DIF
Ortho Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Aug 27, 1982
ENDOSCOPIC SCLEROTHERAPY BALLOON
K821999 · GCP
Retech
Gastroenterology & Urology · 51d
Cleared Aug 27, 1982
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO
K822050 · JJQ
Helena Laboratories
Chemistry · 45d
Cleared Aug 27, 1982
BIOREM 2000
K822099 · LIL
Biorem
Gastroenterology & Urology · 42d
Cleared Aug 27, 1982
MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK
K822125
Welch Allyn, Inc.
Ophthalmic · 39d
Cleared Aug 27, 1982
BINOCULAR OPER. MICROSCOPES & ACCESSOR
K822181 · FSO
Kelleher Corp.
General & Plastic Surgery · 35d
Cleared Aug 27, 1982
ENDOSCOPIC SPONGE CARRIER
K822194 · FGS
Kelleher Corp.
Gastroenterology & Urology · 35d
Cleared Aug 27, 1982
CAVRO IQ-190 SAMPLE PROCESSOR
K822208 · JQW
Cavro Scientific Instruments, Inc.
Chemistry · 35d
Cleared Aug 27, 1982
AUTOLANCET
K822209 · FMK
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 32d
Cleared Aug 27, 1982
ABT 4000 VENTILATOR
K822233 · CBK
Kontron Instruments, Inc.
Anesthesiology · 31d
Cleared Aug 27, 1982
EXAMINATION & TREATMENT CHAIRS
K822251 · GBB
Kelleher Corp.
General & Plastic Surgery · 29d