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
158785–158808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1982
PRIMARY & SECONDARY I.V. TUBING SETS
K822848 · FPA
David Simmonds Co., Inc.
General Hospital · 22d
Cleared Oct 15, 1982
PRO MED 100
K822854 · GZJ
Rebco Trading Co.
Neurology · 18d
Cleared Oct 15, 1982
MODEL 325D UNIPOLAR CARDIAC PULSE GEN
K822904 · DXY
Cook Pacemaker Corp.
Cardiovascular · 16d
Cleared Oct 15, 1982
PHYSICAL MEDICINE & REHABILITATION EQUIP
K822906 · ION
I-Rep, Inc.
Physical Medicine · 16d
Cleared Oct 14, 1982
SYMPTOTHERM 8 FERTILITY INDICATOR
K821507 · LHD
Ovix Corp., Inc.
Obstetrics & Gynecology · 147d
Cleared Oct 13, 1982
DUODERM HYDROACTIVE GRANULES
K821655 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 131d
Cleared Oct 13, 1982
FRANCIS NASAL TUBE
K822130 · FZE
Tekna Med Corp.
General & Plastic Surgery · 86d
Cleared Oct 13, 1982
OPEN HEART TRAY (CUSTOM DESIGNED)
K822158 · KDD
Megaplast, Inc.
General & Plastic Surgery · 82d
Cleared Oct 13, 1982
NAGASHIMA SN OPERATOR'S CHAIR
K822264 · GBB
Kelleher Corp.
General & Plastic Surgery · 76d
Cleared Oct 13, 1982
TRANSFORMER
K822267
Kelleher Corp.
Gastroenterology & Urology · 76d
Cleared Oct 13, 1982
BX-500 ELECTRONIC MUSCLE EXERCISER
K822287 · IPF
Bloomex International, Inc.
Physical Medicine · 75d
Cleared Oct 13, 1982
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · FIP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 65d
Cleared Oct 13, 1982
INNOCOMB LICE COMB
K822421 · LJL
Innovative Products, Inc.
General Hospital · 58d
Cleared Oct 13, 1982
BABY TEMP PACIFIER
K822423 · FQZ
Trp Energy Sensors, Inc.
General Hospital · 62d
Cleared Oct 13, 1982
ACUFEX MAGNETIC RETRIEVER
K822439
Acufex Microsurgical, Inc.
General & Plastic Surgery · 61d
Cleared Oct 13, 1982
SUCTION CATHETER W/STERILE WATER
K822510 · GBX
Medine Dynacor
General & Plastic Surgery · 54d
Cleared Oct 13, 1982
HAWKINS EBA -16 MUSCLE STIMULATOR
K822519 · IPF
A-Zenith Therapeutic Equipment/Supply
Physical Medicine · 51d
Cleared Oct 13, 1982
SPECIAL EYE MIRROR
K822529
Wilmington Optics, Inc.
Ophthalmic · 51d
Cleared Oct 13, 1982
CAPD SAFE LOCK TRANSFER SET
K822543 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 13, 1982
SAFE LOCK SEALING CAP L
K822544 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 13, 1982
CCPD CYCLER SET W/5 PRONGED CONNECTOR
K822545 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 13, 1982
SAFE LOCK SEALING CAPS
K822546 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
SAFE LOCK CATHETER S-3
K822548 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
CCPD CYCLER SET W/5 PRONGED SAFE LOCK
K822549 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 50d