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

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176,076 results
172513–172536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1978
CRONEX QC-1 PROCESSOR
K780248 · IXW
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 17d
Cleared Mar 02, 1978
COBE STOPCOCK
K780271 · DTL
Cobe Laboratories, Inc.
Cardiovascular · 13d
Cleared Mar 02, 1978
RADIATION THERAPY TREAT. PLAN. SYS.
K780278 · JAD
Pfizer Medical Systems, Inc.
Radiology · 13d
Cleared Mar 02, 1978
IMMUFUGE DISP. LINER
K780281 · KSO
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 9d
Cleared Mar 02, 1978
TRIA-PEG RIA DIAG. KIT
K780292 · CDP
Nuclear Diagnostics, Inc.
Toxicology · 9d
Cleared Feb 28, 1978
FLAME PHOTOMETER STANDARD
K772153 · JIT
Alko Scientific Co.
Chemistry · 105d
Cleared Feb 28, 1978
LAS-R HUMAN IGD TEST
K772327 · CZJ
Hyland Therapeutic Div., Travenol...
Immunology · 69d
Cleared Feb 28, 1978
RIALYZE DIGOXIN
K780075 · DPG
Miles Laboratories, Inc.
Toxicology · 43d
Cleared Feb 28, 1978
BED BOARD
K780230 · FPS
Biomet, Inc.
General Hospital · 19d
Cleared Feb 28, 1978
HEMOPEXIN NEPHELOMETRIC ASSAYS
K780250 · CZX
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Feb 28, 1978
BONE CEMENT APPLICATOR
K780266 · KIH
Zimmer, Inc.
Orthopedic · 11d
Cleared Feb 28, 1978
INFLUENZA HA ANTIGEN
K780272 · GNT
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI PRESERUM
K780273 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI ANTISERUM
K780274 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HA ANTIGEN A/USSR
K780275 · GNT
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI ANTISERUM A/TEXAS
K780276 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
INFLUENZA HI PRESERUM A/TEXAS
K780277 · GNS
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Feb 28, 1978
BARRIER HIP PACK W/ FABRIC 450
K780282
Surgikos, Inc.
Physical Medicine · 7d
Cleared Feb 28, 1978
BRACHIAL-LARGE VESSEL APPROXIMATOR
K780286 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 7d
Cleared Feb 28, 1978
BRACHEAL-LARGE VESSEL CLIP
K780288 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 7d
Cleared Feb 28, 1978
ULNAR-RADIAL CLIP
K780290 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 7d
Cleared Feb 28, 1978
ULNAR-RADIAL APPROXIMATER
K780291 · GDJ
Edward Weck, Inc.
General & Plastic Surgery · 7d
Cleared Feb 28, 1978
ELECTRO-SURGICAL GROUNDING PAD
K780298 · GEI
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 6d
Cleared Feb 28, 1978
HIP PLATE REMOVAL INSTRUMENT
K780300 · HWB
Richard'S Medical Equip., Inc.
Orthopedic · 6d