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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87937–87960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1998
MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
K982412 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 88d
Cleared Oct 09, 1998
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
K982428 · HET
Innervision, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 09, 1998
CCA-220
K982441 · EWO
Benson Medical Instruments Co.
Ear, Nose, Throat · 87d
Cleared Oct 09, 1998
DISPOSABLE VINYL EXAM GLOVES, POWDERED
K982687 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 67d
Cleared Oct 09, 1998
MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K982691 · LYY
Perusahaan Intan Emas Sdn. Bhd.
General Hospital · 67d
Cleared Oct 09, 1998
MEDRAD VISTRON CT INJECTOR SYSTEM
K982814 · DXT
Medrad, Inc.
Cardiovascular · 59d
Cleared Oct 09, 1998
STERNOMEGA COMPOMER CEMENT
K982895 · EMA
Sterngold/Implamed
Dental · 53d
Cleared Oct 09, 1998
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS -...
K983162 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 29d
Cleared Oct 09, 1998
CENTAURI
K983211 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 25d
Cleared Oct 09, 1998
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
K983327 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Oct 09, 1998
ONTRAK TESTCUP AND TESTSTIK CONTROLS
K983387 · DIF
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared Oct 09, 1998
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
K983492 · JJY
Boehringer Mannheim Corp.
Chemistry · 4d
Cleared Oct 08, 1998
ULTRACAM
K973410 · EIA
W. Edward Johansen
Dental · 394d
Cleared Oct 08, 1998
MILLENNIUM
K980585 · EFB
Biolase Technology, Inc.
Dental · 233d
Cleared Oct 08, 1998
AIA-PACK TPOAB ASSAY
K981521 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared Oct 08, 1998
AIA-PACK TGAB ASSAY
K981522 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared Oct 08, 1998
RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R
K982436 · GZJ
Woodside Biomedical, Inc.
Neurology · 86d
Cleared Oct 08, 1998
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM
K982484 · HRX
Electro-Biology, Inc.
Orthopedic · 83d
Cleared Oct 08, 1998
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR
K982547 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 79d
Cleared Oct 08, 1998
TEMPBOND CLEAR-2
K982590 · EMA
Sybron Dental Specialties, Inc.
Dental · 76d
Cleared Oct 08, 1998
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
K982732 · HRS
Synthes
Orthopedic · 64d
Cleared Oct 08, 1998
BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K982820 · LLZ
Barco NV Display Systems
Radiology · 58d
Cleared Oct 08, 1998
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
K983222 · MOS
Medical Advances, Inc.
Radiology · 23d
Cleared Oct 07, 1998
HEALTH CHECK URI-TEST PROTEIN IN URINE
K972960 · JIR
Tcpi, Inc.
Chemistry · 422d