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
89017–89040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE...
K981670 · HWC
Depuy, Inc.
Orthopedic · 41d
Cleared Jun 22, 1998
O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100
K981724 · GEI
Medtrex, Inc.
General & Plastic Surgery · 38d
Cleared Jun 22, 1998
ALKP
K981806 · CJE
Abbott Laboratories
Chemistry · 32d
Cleared Jun 22, 1998
HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
K981893 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 24d
Cleared Jun 22, 1998
MRS-400, MAXI 400, MRSL-400, MAXI 400L
K981990 · EFB
D.B.I. America Corp.
Dental · 14d
Cleared Jun 19, 1998
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
K973013 · LIT
Vas-Cath, Inc.
Cardiovascular · 310d
Cleared Jun 19, 1998
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM
K980728 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 114d
Cleared Jun 19, 1998
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K980873 · LMA
Konica Corp.
Radiology · 105d
Cleared Jun 19, 1998
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
K981286 · KDH
Armm, Inc.
Gastroenterology & Urology · 72d
Cleared Jun 19, 1998
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
K981328 · MOB
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Jun 19, 1998
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
K981330 · MOB
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Jun 19, 1998
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
K981470 · IZH
Worldwide Medical Technologies, LLC
Radiology · 57d
Cleared Jun 19, 1998
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K981621 · LTZ
Suretex Prophylactics (India) , Ltd.
Obstetrics & Gynecology · 44d
Cleared Jun 19, 1998
URIC ACID
K981766 · CDO
Abbott Laboratories
Chemistry · 31d
Cleared Jun 18, 1998
DURACON(R) SMALL STABILIZER TIBIAL INSERT
K974843 · JWH
Howmedica Corp.
Orthopedic · 176d
Cleared Jun 18, 1998
KOALA VASCULAR CLAMPS AND INSERTS
K980002 · DXC
Boss Instruments, Ltd.
Cardiovascular · 167d
Cleared Jun 18, 1998
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
K981053 · LMD
Eastman Kodak Company
Radiology · 87d
Cleared Jun 18, 1998
MEDRAD NEUROVASCULAR COIL
K981094 · MOS
Medrad, Inc.
Radiology · 84d
Cleared Jun 18, 1998
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
K981167 · CAF
Dhd Healthcare Corp.
Anesthesiology · 78d
Cleared Jun 18, 1998
PLATINUM READING, REVIEW & ANALYSIS WORKSTATION
K981217 · LLZ
GE Medical Systems
Radiology · 76d
Cleared Jun 18, 1998
NFC NEEDLEFREE Y-SITE, MODEL 69970
K981547 · FPA
Filtertek, Inc.
General Hospital · 49d
Cleared Jun 18, 1998
NFC NEEDLEFREE CONNECTOR MODEL 69900
K981548 · FPA
Filtertek, Inc.
General Hospital · 49d
Cleared Jun 18, 1998
PHILIPS THORAVISION
K981657 · KPR
Philips Medical Systems North...
Radiology · 38d
Cleared Jun 17, 1998
COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO
K973864 · IZF
Pausch Corp.
Radiology · 251d