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
78889–78912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2001
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
K011271 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 12d
Cleared May 07, 2001
ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
K003403 · JOS
Highland / Marietta, Inc.
General & Plastic Surgery · 187d
Cleared May 07, 2001
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS...
K003405 · KNF
Highland / Marietta, Inc.
Obstetrics & Gynecology · 187d
Cleared May 07, 2001
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
K010361 · GXR
Medtronic PS Medical
Neurology · 90d
Cleared May 07, 2001
D/C CORE MATERIAL
K010475 · EBF
Parkell, Inc.
Dental · 76d
Cleared May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · CGA
Instrumentation Laboratory CO
Chemistry · 74d
Cleared May 07, 2001
ACON STREP A RAPID TEST STRIP
K010582 · GTY
Acon Laboratories Co.
Microbiology · 69d
Cleared May 07, 2001
ATLAST DATA MANAGEMENT SOFTWARE (DMS)
K010605 · CGA
Amira Medical, Inc.
Chemistry · 68d
Cleared May 07, 2001
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
K010666 · QPB
Medtronic Xomed, Inc.
General & Plastic Surgery · 62d
Cleared May 07, 2001
XPS 3000 SYSTEM
K010677 · HRX
Medtronic Xomed, Inc.
Orthopedic · 61d
Cleared May 07, 2001
SIMPLICT
K010813 · JAK
Neorad AS
Radiology · 49d
Cleared May 04, 2001
TETRAD TC-C3-ACP
K002193 · ITX
Tetrad Corp.
Radiology · 288d
Cleared May 04, 2001
REMREST
K002763 · BZD
Medical Industries America, Inc.
Anesthesiology · 241d
Cleared May 04, 2001
MPS M ELECTRODE
K002801 · LNS
Medical Physics and Services, Inc.
Gastroenterology & Urology · 238d
Cleared May 04, 2001
RENAX A.V. FISTULA NEEDLE SETS
K003123 · FIE
Sunder Biomedical Tech. Co., Ltd.
Gastroenterology & Urology · 211d
Cleared May 04, 2001
MODIFICATION TO EDI VERIS SYSTEM
K003442 · HLX
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 179d
Cleared May 04, 2001
DEVILBISS HUMIDIFIER
K003626 · BTT
Sunrise Medical Hhg, Inc.
Anesthesiology · 161d
Cleared May 04, 2001
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K003943 · KLK
Linde Medical Sensors AG
Anesthesiology · 134d
Cleared May 04, 2001
IVD (IN VIVO DOSIMETER), MODEL 1131
K010449 · IYE
Sun Nuclear Corp.
Radiology · 78d
Cleared May 04, 2001
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
K011050 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 28d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared May 04, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER...
K011098 · MXC
Medtronic Vascular
Cardiovascular · 23d
Cleared May 04, 2001
APEX FIXATION PINS
K011136 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 04, 2001
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
K011178 · LQC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 17d