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
139297–139320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1987
MMG DELEE SUCTION CATHETER W/MUCOUS TRAP
K871949 · BSY
Medical Technologies of Georgia
Anesthesiology · 26d
Cleared Jun 15, 1987
BEAR JET VENTILATOR FOR USE DURING (ESWL)
K871985 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 24d
Cleared Jun 15, 1987
MODEL TPC-1A OXYGEN ANALYZER
K872001 · CCL
Medical, Inc.
Anesthesiology · 20d
Cleared Jun 15, 1987
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
K872056 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 18d
Cleared Jun 15, 1987
CORNING DISPOSABLE ROLLER BOTTLES
K872076 · KJB
Corning Medical & Scientific
Pathology · 17d
Cleared Jun 15, 1987
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
K872079 · MSJ
Reagents Applications, Inc.
Immunology · 17d
Cleared Jun 15, 1987
RAICHEM(TM) SPIA(TM) APO B REAGENTS
K872080 · DFC
Reagents Applications, Inc.
Immunology · 17d
Cleared Jun 15, 1987
CIPRO (TM) DIAGNOSTIC POWDER
K872081 · JTT
Miles Pharmaceuticals
Microbiology · 17d
Cleared Jun 15, 1987
ACUSYST-JR
K872086 · KJH
Endotronics, Inc.
Pathology · 14d
Cleared Jun 15, 1987
MCBRIDE MEDIUM CM 819
K872135 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 12d
Cleared Jun 15, 1987
(MSI) PATH-SAVER
K872140 · IFP
Medical Specialties, Inc.
Pathology · 13d
Cleared Jun 12, 1987
PULSE CUFF RECORDER MODEL PCR100
K863702 · JOM
Imex Medical Systems, Inc.
Cardiovascular · 262d
Cleared Jun 12, 1987
TATCH-IT
K870356 · DRS
Reunion Medical Co.
Cardiovascular · 134d
Cleared Jun 12, 1987
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
K870840 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 106d
Cleared Jun 12, 1987
MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.
K871077 · GEI
Radionics, Inc.
General & Plastic Surgery · 86d
Cleared Jun 12, 1987
SIGMA'S CALCIUM PROCEDURE NO. 587
K871152 · CIC
Sigma Diagnostics, Inc.
Chemistry · 81d
Cleared Jun 12, 1987
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
K871348 · LNK
Sharplan Lasers, Inc.
Gastroenterology & Urology · 67d
Cleared Jun 12, 1987
DIGITAL SPHYGMOMANOMETER
K871371 · DRS
Omron Tateisi Electronics Co.
Cardiovascular · 66d
Cleared Jun 12, 1987
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
K871471 · FJI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 59d
Cleared Jun 12, 1987
VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH
K871487 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 58d
Cleared Jun 12, 1987
VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH
K871488 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 58d
Cleared Jun 12, 1987
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
K871489 · DBF
Diagnostic Systems Laboratories, Inc.
Immunology · 58d
Cleared Jun 12, 1987
DELFIA(TM) HIGE KIT
K871599 · DHB
Lkb Instruments, Inc.
Immunology · 49d
Cleared Jun 12, 1987
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
K871604 · LXP
Advanced Surgical Products, Inc.
Ophthalmic · 49d