FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88273–88296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1998
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
K982916 · MOS
Medrad, Inc.
Radiology · 71d
Cleared Oct 29, 1998
XCT 2000 L PQCT BONE DENSITOMETER
K983273 · KGI
Medical Systems, Inc.
Radiology · 42d
Cleared Oct 29, 1998
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
K983436 · JAQ
Gammamed USA
Radiology · 30d
Cleared Oct 29, 1998
WISE (II) IMAGE MANAGEMENT SYSTEM
K983447 · LMB
Sectra-Imtec AB
Radiology · 29d
Cleared Oct 29, 1998
GENESIS BLS
K983643 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 13d
Cleared Oct 29, 1998
EMT RESUSCITATOR
K983705 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 8d
Cleared Oct 29, 1998
AUTOVENT 1000
K983785 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 2d
Cleared Oct 28, 1998
SPIROCARD
K973138 · BZG
Qrs Diagnostic, LLC
Anesthesiology · 433d
Cleared Oct 28, 1998
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
K974581 · DRT
Invivo Research, Inc.
Cardiovascular · 324d
Cleared Oct 28, 1998
HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980799 · EBG
Cosmedent, Inc.
Dental · 240d
Cleared Oct 28, 1998
CLEARPLAN EASY FERTILITY MONITOR
K981207 · NGE
Unipath , Ltd.
Chemistry · 209d
Cleared Oct 28, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K981528 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 182d
Cleared Oct 28, 1998
HANDISOL WOUND HEALING
K982082 · FTC
National Biological Corp.
General & Plastic Surgery · 135d
Cleared Oct 28, 1998
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
K982225 · BTL
Spiracle Technology
Anesthesiology · 126d
Cleared Oct 28, 1998
VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
K982541 · FMI
Becton Dickinson Vacutainer Systems
General Hospital · 99d
Cleared Oct 28, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE...
K982662 · HWC
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Oct 28, 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · FYA
Medline Industries, Inc.
General Hospital · 86d
Cleared Oct 28, 1998
MAICO MA42
K982723 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 28, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
K982733 · ITX
The Olympus Optical Co.
Radiology · 84d
Cleared Oct 28, 1998
PIEZO TRONIC
K982793 · ELC
Advanced Medical Devices, Inc.
Dental · 79d
Cleared Oct 28, 1998
SHELHIGH NO-REACT VASCUPATCH
K982810 · DXZ
Shelhigh, Inc.
Cardiovascular · 78d
Cleared Oct 28, 1998
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
K982970 · EZL
Mri Manufacturing and Research, Inc.
Gastroenterology & Urology · 64d
Cleared Oct 28, 1998
AUROLLOYD KF
K983080 · EJT
Bego U.S.A.
Dental · 56d
Cleared Oct 28, 1998
BEGOPAL 300
K983081 · EJS
Bego Bremer Goldschlaegerei Wilh....
Dental · 56d