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
164737–164760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1981
SIEMENS PHO/SONIC ALPHA 1000
K802759 · IYO
Siemens Gammasonics, Inc.
Radiology · 64d
Cleared Jan 07, 1981
6MV PORT FILM CAPABILITY OPTION
K802808 · IYE
Varian Assoc., Inc.
Radiology · 61d
Cleared Jan 07, 1981
ELECTRON ARC THERAPY
K802809 · IYE
Varian Assoc., Inc.
Radiology · 61d
Cleared Jan 07, 1981
MODEL HEC-7 HEART EVALUATION COMPUTER
K802952 · DPS
Kluwe Corp.
Cardiovascular · 48d
Cleared Jan 07, 1981
I.V. ADDITIVE CAP
K802966 · KPE
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 47d
Cleared Jan 07, 1981
NUFFIELD ANESTHESIA VENTILATOR SER. 400
K803052 · BSZ
Penlon, Inc.
Anesthesiology · 36d
Cleared Jan 07, 1981
CATH-SECURE
K803062 · KOD
Melissa C. Johnson
Gastroenterology & Urology · 34d
Cleared Jan 06, 1981
DRESSING CHANGE FOR G TUBE
K803115 · FRO
American Medical Disposable, Inc.
General & Plastic Surgery · 27d
Cleared Jan 06, 1981
REGULATOR VENOSET W/0.22 MICRON IVEX
K810029
Abbott Laboratories
General Hospital
Cleared Jan 05, 1981
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
K802448 · DHR
Syn-Kit, Inc.
Immunology · 89d
Cleared Jan 05, 1981
TEST KIT FOR DETECTION OF ANTINUCLEAR
K802527 · DHN
Bartels & Stout, Inc.
Immunology · 82d
Cleared Jan 05, 1981
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
K802610 · DER
Hyland Therapeutic Div., Travenol...
Immunology · 76d
Cleared Jan 05, 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC
K802964 · FSM
Associated Medical Products Co.
General & Plastic Surgery · 45d
Cleared Jan 05, 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418
K802965 · FSM
Associated Medical Products Co.
General & Plastic Surgery · 45d
Cleared Jan 05, 1981
NON-CONDUCTIVE ANESTHESIA FACE MASK
K803185 · BSJ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 20d
Cleared Jan 05, 1981
MICROSURG CAUTERY
K810017 · HQO
Medical Products Development, Inc.
Ophthalmic
Cleared Jan 02, 1981
CREST ELECTRONIC WARMING BLANKET
K801253 · DWJ
Penlon, Inc.
Cardiovascular · 219d
Cleared Jan 02, 1981
ATRIAL/VENTRICULAR SEQENTIAL #080-20000
K801799 · LDF
Medical Testing System, Inc.
Cardiovascular · 157d
Cleared Jan 02, 1981
ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE
K801802 · DPW
Medical Testing System, Inc.
Cardiovascular · 157d
Cleared Jan 02, 1981
IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS
K802413 · DTB
Telectronics, Inc.
Cardiovascular · 88d
Cleared Jan 02, 1981
K-KATH URETHRAL CATHETER INTRODUCER
K802878 · KOD
B&K Medical
Gastroenterology & Urology · 46d
Cleared Jan 02, 1981
CORTISOL 125-I RADIOIMMUNOASSAY KIT
K802969 · CGR
Ria Products, Inc.
Chemistry · 42d
Cleared Jan 02, 1981
LEECO TESTO-QUANT DIAGNOSTIC KIT
K803001 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 38d
Cleared Jan 02, 1981
CHLORIDE/TCO2 ANALYZER REAGENTS
K803013 · CHJ
Laboratory Products, Inc.
Chemistry · 35d