FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134257–134280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1988
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
K873674 · JOP
Shimadzu Corp.
Cardiovascular · 392d
Cleared Oct 07, 1988
LENZ CLENZER
K881739 · LYL
Lens Care, Inc.
Ophthalmic · 165d
Cleared Oct 07, 1988
VIADERM
K882590 · KGN
Applied Biomedical Sciences
General & Plastic Surgery · 106d
Cleared Oct 07, 1988
DVS (OPTION 01)
K883101 · IYE
O.M.I. Oncology Microsystems, Inc.
Radiology · 77d
Cleared Oct 07, 1988
AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR
K883483 · CAN
Autoflow Products, Co.
Anesthesiology · 52d
Cleared Oct 07, 1988
DIASONICS MT/P IMAGING SYSTEM
K883516 · LNH
Diasonics, Inc.
Radiology · 52d
Cleared Oct 07, 1988
0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST
K883520 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 50d
Cleared Oct 07, 1988
TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER
K883546 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 49d
Cleared Oct 07, 1988
WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE
K883876 · GDM
E.G. Dick & Assoc.
General & Plastic Surgery · 24d
Cleared Oct 07, 1988
RANEY AND LEROY-RANEY SCALP CLIP
K883963 · HBO
New England Surgical Instrument Corp.
Neurology · 17d
Cleared Oct 07, 1988
NON-REBREATHING TEE PIECE (NRTP)
K883988 · CBP
Dhd Medical Products Div. Diemolding...
Anesthesiology · 17d
Cleared Oct 07, 1988
MASTER-GUARD
K884041 · KCT
Sparco, Inc.
General Hospital · 11d
Cleared Oct 07, 1988
ROCKET CERVICAL SPATULA
K884042 · HHT
A & A Medical, Inc.
Obstetrics & Gynecology · 11d
Cleared Oct 07, 1988
15 MILLIMETER MALE AND FEMALE ADAPTERS
K884072 · CAI
Eastmed Enterprises, Inc.
Anesthesiology · 10d
Cleared Oct 07, 1988
SUREBREATH DOME
K884076 · GAD
Ipax, Inc.
General & Plastic Surgery · 10d
Cleared Oct 06, 1988
POCKET MANOMETER
K880599 · DXN
Abbott Laboratories
Cardiovascular · 238d
Cleared Oct 06, 1988
MICROMEDIC CRACKPOT RIA KIT
K880674 · KLN
Icn Micromedic Systems
Toxicology · 230d
Cleared Oct 06, 1988
B. FRAGTEX
K881380 · JSP
American Biomedical Products, Inc.
Microbiology · 188d
Cleared Oct 06, 1988
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
K881983 · LWJ
Howmedica Corp.
Orthopedic · 147d
Cleared Oct 06, 1988
CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
K882199 · LYR
Auspharm Intl. , Ltd.
Microbiology · 134d
Cleared Oct 06, 1988
PACER SENSING ANALYZER (PSA 100)
K882327 · DTC
Oscor Medical Corp.
Cardiovascular · 122d
Cleared Oct 06, 1988
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K882380 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 119d
Cleared Oct 06, 1988
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
K882475 · LFX
Amersham Corp.
Microbiology · 113d
Cleared Oct 06, 1988
BLUE DOT(TM) TEST FOR PREGNANCY
K882588 · LCX
V-Tech, Inc.
Chemistry · 105d