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
166897–166920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1980
STOMACH TUBES
K800508 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
RECTAL & HARRIS FLUSH TUBES
K800510 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
MEDICAL COMPONENTS IV CATHETER
K800525 · FOZ
Medical Components, Inc.
General Hospital · 32d
Cleared Apr 08, 1980
DISP. HYDROGEN & CO2 GENERATOR ENVELOPE
K800539 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Apr 08, 1980
CAMBRIDGE VS-550 ELECTROCARDIOGRAPH
K800566 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 26d
Cleared Apr 08, 1980
SYRINGE INFUSION PUMP #2720
K800569 · FRN
Harvard Apparatus, Inc.
General Hospital · 25d
Cleared Apr 08, 1980
BETA-ASE TUBES
K800579 · JTO
Microchemical Specialities, Co.
Microbiology · 25d
Cleared Apr 08, 1980
SUPRAPUBIC TROCAR
K800607 · KOB
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
STONE DISLODGER
K800608 · FFL
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
URETHRAL SOUND
K800610 · KOE
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
BOUGIE A BOULE
K800611 · KOE
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
ANGIOPLASTY INJECTOR
K800613 · DXT
Medrad, Inc.
Cardiovascular · 21d
Cleared Apr 08, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
K800645 · DXY
Intermedics, Inc.
Cardiovascular · 15d
Cleared Apr 08, 1980
SCHILLER MSG-1
K800659 · DPS
Renesco International, Inc.
Cardiovascular · 13d
Cleared Apr 08, 1980
MODEL S/D-600 AUTO INFLATE CONTROL MODUL
K800661 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MARK II
K800662 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MARK III
K800663 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MODIFIED CATHETER PACKAGE
K800703 · DQO
Hancock Laboratories, Inc.
Cardiovascular · 12d
Cleared Apr 08, 1980
PROBE
K800729 · HXB
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 08, 1980
RETROGRADE KNIFE
K800730 · HXP
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 08, 1980
MENISCAL SAW
K800731 · HXP
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 08, 1980
MENISCOTOME
K800732 · HXP
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 08, 1980
DOUBLE-EDGE CURETTE
K800733 · HXP
Stainless Mfg., Inc.
Orthopedic · 7d
Cleared Apr 04, 1980
ANTIMICROBIAL REMOVAL DEVICE (ARD)
K800052
Marion Laboratories, Inc.
Microbiology · 86d