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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
147457–147480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 05, 1985
DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
K853558
American White Cross, Inc.
General & Plastic Surgery · 10d
Cleared Sep 04, 1985
ASCON OPHTHALMIC SPONGE
K852055 · HOZ
Ascon Medical Instruments, Ltd.
Ophthalmic · 118d
Cleared Sep 04, 1985
SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT
K852386 · LPN
Barnes-Hind, Inc.
Ophthalmic · 91d
Cleared Sep 04, 1985
PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY
K852845 · JFH
Diagnostic Products Corp.
Chemistry · 61d
Cleared Sep 04, 1985
WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST
K852949 · KZF
Welch Allyn, Inc.
General Hospital · 55d
Cleared Sep 04, 1985
HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY
K853006 · JHI
Modern Diagnostics, Inc.
Chemistry · 50d
Cleared Sep 04, 1985
MST MODEL #ARLG-5
K853061
Marlo Surgical Technology
Ophthalmic · 47d
Cleared Sep 04, 1985
ACU-SLIDE-TEST
K853247 · JHJ
Cal-Tech Diagnostics, Inc.
Toxicology · 34d
Cleared Sep 04, 1985
FREEMAN UNI-COMPARTMENTAL KNEE
K853268 · HSX
Protek, Inc.
Orthopedic · 30d
Cleared Sep 04, 1985
GEMSTAR IPA THEOPHYLLINE TEST KIT
K853372 · KLS
Electro-Nucleonics Laboratories, Inc.
Toxicology · 23d