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
121129–121152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1991
INTRAN PLUS
K905563 · KXO
Utah Medical Products, Inc.
Obstetrics & Gynecology · 189d
Cleared Jun 19, 1991
XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A
K905573 · BSS
Zeon Medical Corp.
Gastroenterology & Urology · 189d
Cleared Jun 19, 1991
PORTABLE AUTO TRANSFUSION SYSTEM 500
K910238 · CAC
Electromedics, Inc.
Anesthesiology · 152d
Cleared Jun 19, 1991
ZODIAC 901 MIDDLE-EAR ANALYZER
K910247 · ETY
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 148d
Cleared Jun 19, 1991
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
K910990 · JWH
Osteonics Corp.
Orthopedic · 104d
Cleared Jun 19, 1991
CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP
K911243 · GCJ
Northgate Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jun 19, 1991
VARIOUS X-RAY TUBES
K911695 · ITY
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 64d
Cleared Jun 19, 1991
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
K912469 · BTO
Bivona Medical Technologies
Anesthesiology · 15d
Cleared Jun 18, 1991
VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM
K904328 · GWK
Telediagnostic Systems, Inc.
Neurology · 271d
Cleared Jun 18, 1991
CENTAURI YAG LASER SYST, NEUROSURGERY
K904631 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 252d
Cleared Jun 18, 1991
2710-000 OSCILLATING SAW, GENERAL ASSEMBLY
K905383 · GEY
Micro Surgical Instruments Corp.
General & Plastic Surgery · 201d
Cleared Jun 18, 1991
LEVTECH TITANIUM BONE WIRE
K910128 · JDQ
Levtech, Inc.
Orthopedic · 160d
Cleared Jun 18, 1991
LIFE-02 (NON-REFILLABLE CYLINDER)
K910699 · BTL
Life Corp.
Anesthesiology · 119d
Cleared Jun 18, 1991
MANUAL RESUSCITATOR
K910856 · BTM
Vital Signs, Inc.
Anesthesiology · 110d
Cleared Jun 18, 1991
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
K911110 · HPZ
G.W.B. Intl., Ltd.
Ophthalmic · 106d
Cleared Jun 18, 1991
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
K911153 · LCM
Immunotech Corp.
Toxicology · 95d
Cleared Jun 18, 1991
MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS
K911236 · DYB
Medtronic Vascular
Cardiovascular · 90d
Cleared Jun 18, 1991
CERION HAND HELD OXYGEN ANALYZER
K911344 · CCL
Ceramatec, Inc.
Anesthesiology · 83d
Cleared Jun 18, 1991
INFANT VENTILATOR
K911450 · CBK
Preemicare Corp.
Anesthesiology · 85d
Cleared Jun 18, 1991
LUNG DIFFUSION GAS MIXTURES
K911471 · BXK
Norco, Inc.
Anesthesiology · 76d
Cleared Jun 18, 1991
CERAPALL
K911670 · EJS
Metalor Dental USA Corp.
Dental · 68d
Cleared Jun 18, 1991
MAXIBOND
K911757 · EJS
Argen Precious Metals, Inc.
Dental · 61d
Cleared Jun 18, 1991
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT
K911839 · JLX
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 54d
Cleared Jun 18, 1991
LUER LOCK INJECTION CAP
K911931 · FPA
Dmd Products
General Hospital · 49d