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
158353–158376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1982
TRACTION-STEEL FRAMING SYSTEM
K823395 · HST
Orthopedic Systems, Inc.
Neurology · 21d
Cleared Dec 03, 1982
HEYER-SCHUTE UNIVERSAL URETERAL STENT
K823418 · LJE
American Hospital Supply Corp.
Gastroenterology & Urology · 18d
Cleared Dec 03, 1982
FISCH MODIFIED TEF-WIRE PISTON
K823429 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
HEARING AID #G6H & G6T
K823431 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
CAUSSE TEF-PISTON
K823439 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
MCGEE MODIFIED STAINLESS STEEL PISTON
K823440 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823441 · LBM
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
FISCH MODIFIED TOTAL OSSICULAR PROSTHES
K823442 · LBM
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
HERPES TRANSETTE
K823443 · JTW
Spectrum Diagnostic, Inc.
Microbiology · 17d
Cleared Dec 03, 1982
PRODUCTS IMPLANTABLE PACING LEAD,TINED
K823446 · DTB
Oscor, Inc.
Cardiovascular · 17d
Cleared Dec 03, 1982
IMPLANTABLE PACING LEAD, TINED #3262 &
K823447 · DTB
Vascular Products, Inc.
Cardiovascular · 17d
Cleared Dec 03, 1982
IMPLANTABLE PACING LEAD TINED #3390 &
K823448 · DTB
Oscor, Inc.
Cardiovascular · 17d
Cleared Dec 03, 1982
MODELS G6H, G6T, G1H & G1T
K823460 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 14d
Cleared Dec 03, 1982
MODEL H 37E
K823468 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared Dec 03, 1982
SURE SNIP
K823485 · EFQ
South Mountain Medical
General & Plastic Surgery · 10d
Cleared Nov 30, 1982
MEDTRONIC MODELS 4011 & 4511
K822781 · DTB
Medtronic Vascular
Cardiovascular · 77d
Cleared Nov 30, 1982
RIGHT ATRIAL CATHETER
K822964 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 56d
Cleared Nov 30, 1982
THE 500 MONITOR SERIES
K823052 · DXN
Vitatek
Cardiovascular · 43d
Cleared Nov 30, 1982
FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB
K823063 · FRN
Travenol Laboratories, S.A.
General Hospital · 43d
Cleared Nov 30, 1982
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT
K823108 · DTM
Extracorporeal Medical Specialities,...
Cardiovascular · 40d
Cleared Nov 30, 1982
AMBULATORY INSULIN INFUSION PUMP 9205
K823193 · FRN
Cpi, Inc.
General Hospital · 35d
Cleared Nov 30, 1982
BETATRON II
K823204 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 34d
Cleared Nov 30, 1982
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217 · FKX
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Nov 30, 1982
CADIO-RESPIRATORY MONITOR #CR-2
K823312 · DRT
Electromed Intl., Ltd.
Cardiovascular · 25d