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
82393–82416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2000
JET PORT PLUS CATHETER SYSTEM
K000125 · LJT
Clinical Plastic Products SA
General Hospital · 85d
Cleared Apr 12, 2000
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
K000127 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 85d
Cleared Apr 12, 2000
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD...
K000275 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 72d
Cleared Apr 12, 2000
INCENTIVE SPIROMETER
K000314 · BWF
Engineered Medical Systems
Anesthesiology · 71d
Cleared Apr 12, 2000
MTP DISPOSABLE TROCAR VALVES
K000337 · GCJ
Mtp Medical Technical Promotion GmbH
General & Plastic Surgery · 69d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000390 · LYY
Sgmp Co., Ltd.
General Hospital · 65d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000391 · LYY
Sgmp Co., Ltd.
General Hospital · 65d
Cleared Apr 12, 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · EBZ
Bisco, Inc.
Dental · 63d
Cleared Apr 12, 2000
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN &...
K000555 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 54d
Cleared Apr 12, 2000
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50...
K000584 · LYY
Shasta Asia Partners Gloves...
General Hospital · 50d
Cleared Apr 12, 2000
NITRILE EXAM GLOVE, POWDER FREE, BLUE
K000670 · LZA
Shasta Asia Partners Gloves...
General Hospital · 44d
Cleared Apr 12, 2000
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
K000688 · LZA
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 43d
Cleared Apr 12, 2000
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
K000740 · MQX
Asahi Iryoki Co., Ltd.
General Hospital · 36d
Cleared Apr 12, 2000
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K000793 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Apr 12, 2000
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
K001008 · FLL
Oriental System Technology, Inc.
General Hospital · 14d
Cleared Apr 12, 2000
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC...
K991677 · LYY
London International Group, Inc.
General Hospital · 331d
Cleared Apr 12, 2000
IQ CHAMBERS
K992553 · KXF
Dormer Laboratories, Inc.
General Hospital · 257d
Cleared Apr 12, 2000
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
K993116 · FLL
A&D Engineering, Inc.
General Hospital · 205d
Cleared Apr 12, 2000
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K994099 · LYZ
Evergreen Medical Produts (Jingxing)...
General Hospital · 131d
Cleared Apr 11, 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · MRC
Alcon Laboratories
Ophthalmic · 84d
Cleared Apr 11, 2000
CORTEK ARTHROSCOPE
K000198 · HRX
Cortek Endoscopy, Inc.
Orthopedic · 81d
Cleared Apr 11, 2000
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE...
K000221 · OWB
Ge Dec Medical Systems
Radiology · 78d
Cleared Apr 11, 2000
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
K000345 · MOS
Medical Advances, Inc.
Radiology · 68d
Cleared Apr 11, 2000
SCREENERS COCAINE TEST
K000350 · DIO
Drug Detection Devices, Ltd.
Toxicology · 68d