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
146857–146880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1985
EZX YELLOW, BLUE OR ORANGE
K852170 · EGZ
Strong Marketing
Dental · 108d
Cleared Sep 05, 1985
URETERAL STENT
K852389 · FAD
American Medical Systems, Inc.
Gastroenterology & Urology · 92d
Cleared Sep 05, 1985
LGT TUBE
K852413 · BTO
Mallinckrodt Critical Care
Anesthesiology · 91d
Cleared Sep 05, 1985
CAST-TECH CO. COOLING SYSTEM
K852495 · ILO
Cast-Tech Co.
Physical Medicine · 85d
Cleared Sep 05, 1985
BAND-AID BRAND ADHESIVE BANDAGES
K852545 · FRO
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 83d
Cleared Sep 05, 1985
FREEMAN ACETABULAR CUP
K852699 · KWA
Advanced Biosearch Assn.
Orthopedic · 71d
Cleared Sep 05, 1985
HGM ENDOCOAGULATOR MODEL 20
K852913
Hgm, Inc.
Gastroenterology & Urology · 56d
Cleared Sep 05, 1985
FLEXIMATIC MASSAGER
K852944 · ISA
General Physiotherapy, Inc.
Physical Medicine · 56d
Cleared Sep 05, 1985
THORO/CATH STRAIGHT THORACIC RIGHT ANGLE
K853131 · GBS
J. H. Emerson Co.
General & Plastic Surgery · 41d
Cleared Sep 05, 1985
RELIANCE 1000, RELIANCE 1500, RELIANCE 2000
K853149 · HME
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Sep 05, 1985
RELIANCE 6100
K853150 · HME
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Sep 05, 1985
RELIANCE 5000
K853151 · HME
F. & F. Koenigkramer
Ophthalmic · 38d
Cleared Sep 05, 1985
CHURCHILL VENTED IV SET
K853204 · FPA
Churchill Corp.
General Hospital · 37d
Cleared Sep 05, 1985
MAI STERILE UTILITY DRAPE
K853347 · KKX
Medical Assoc. Intl., Inc.
General Hospital · 24d
Cleared Sep 05, 1985
H-H RICKHAM TYPE RESERVOIR
K853364 · JXG
Holter-Hausner Intl.
Neurology · 24d
Cleared Sep 05, 1985
H-H FIFTH VENTRICLE
K853365 · JXG
Holter-Hausner Intl.
Neurology · 24d
Cleared Sep 05, 1985
CORRECT-A-COUNT
K853374
Dermacare Products, Inc.
General & Plastic Surgery · 24d
Cleared Sep 05, 1985
SURE COUNT 5 & 10 SPONGE COUNTER
K853454
Kleen Test Products
General & Plastic Surgery · 20d
Cleared Sep 05, 1985
ENDO L 300 LIGHT, ILLUMINATING WOUND RECTRACTOR
K853460
Heraeus, Inc.
General & Plastic Surgery · 17d
Cleared Sep 05, 1985
GRAM-MA NEONATAL SC
K853475 · FRW
Kentec Medical, Inc.
General Hospital · 16d
Cleared Sep 05, 1985
SKYTRON ELITE 300 SURGERY TABLE
K853479 · FWW
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 16d
Cleared Sep 05, 1985
REUSABLE JACOBS DRILL CHUCK
K853495
Chattanooga Group, Inc.
General & Plastic Surgery · 16d
Cleared Sep 05, 1985
STERI-GRIP
K853507
Clinical Technology Corp.
General & Plastic Surgery · 15d
Cleared Sep 05, 1985
QUAD FERM +
K853544 · JSX
Analytical Products, Inc.
Microbiology · 10d