Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
157489–157512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1983
PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION
K830871 · HOC
Phakosystems, Inc.
Ophthalmic · 76d
Cleared Jun 02, 1983
AMPERCIDE DISINFECTANT ACCESSORY TO -
K830881 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 76d
Cleared Jun 02, 1983
160/260 SUCTION COAGULATOR
K830926 · GEI
Zimmer, Inc.
General & Plastic Surgery · 71d
Cleared Jun 02, 1983
BAKER JEJUNOSTOMY TUBE
K830989 · KNT
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 02, 1983
BLAKEMORE TUBE
K830990 · KNT
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 02, 1983
ESOPHAGEAL BOUGIES
K830991 · KNQ
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 02, 1983
ARIA II I-HCG
K830997 · JHI
Bd Becton Dickinson Vacutainer...
Immunology · 65d
Cleared Jun 02, 1983
MILLER-ABBOTT TUBE
K830998 · KNT
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 02, 1983
CANTOR TUBE
K831009 · KNT
Medovations, Inc.
Gastroenterology & Urology · 64d
Cleared Jun 02, 1983
DUOCLON SLIDE TEST
K831109 · JHI
Organon, Inc.
Immunology · 58d
Cleared Jun 02, 1983
B-CLONE HCG ASSAY
K831155 · JHJ
Monoclonal Antibodies, Inc.
Chemistry · 55d
Cleared Jun 02, 1983
ARUBI FLATTER & ARUBI FLATTER-S
K831206 · ISA
Kc Export Management Co.
Physical Medicine · 50d
Cleared Jun 02, 1983
RIAGEN B-HCG RIA KIT
K831221 · JHI
Biogenex Laboratories
Chemistry · 48d
Cleared Jun 02, 1983
BETA-QUIK-15 RIA KIT
K831223 · JHI
Pacific Biotech, Inc.
Chemistry · 48d
Cleared Jun 02, 1983
COMPUR EASY TOUCH CHEMISTRY ANALYZER-
K831227 · JJF
Worthington Diagnostic Systems
Chemistry · 48d
Cleared Jun 02, 1983
GLENOID RESURFACE COMPONENT PMN 3M
K831234 · KWT
3M Company
Orthopedic · 48d
Cleared Jun 02, 1983
BIPOLAR CARD
K831236 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 48d
Cleared Jun 02, 1983
QST TM SAMPLE PROCESSOR
K831273 · JQW
Syva Co.
Chemistry · 44d
Cleared Jun 02, 1983
ELECTROSURGICAL UNIT-MF 380 #60-1700
K831291 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 43d
Cleared Jun 02, 1983
EVEN-TEMP. CAPACITIVE ADHESIVE PAD
K831299 · GEI
Delta Medical Electronics, Inc.
General & Plastic Surgery · 42d
Cleared Jun 02, 1983
EMIT QST GENTAMICIN ASSAY
K831304 · LCD
Syva Co.
Immunology · 42d
Cleared Jun 02, 1983
NUTROMAT
K831325 · GBB
Medlog GmbH Marketing Services
General & Plastic Surgery · 38d
Cleared Jun 02, 1983
ALLERCOAT ALLERGEN DISCS
K831326 · DGC
Kallestad Laboratories, Inc.
Immunology · 38d
Cleared Jun 02, 1983
API UNISCEPT PLUS AUTOINOCULATOR
K831341 · JTC
Analytical Products, Inc.
Immunology · 38d