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
103393–103416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1995
MULTI-DRUG CONTROL SET
K951135 · DIF
Microgenics Corp.
Chemistry · 31d
Cleared Apr 13, 1995
COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)
K951137 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 31d
Cleared Apr 13, 1995
SCIPOTEX
K951171 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 29d
Cleared Apr 13, 1995
IMEDGE VIDEO OSTOSCOPE (ANALOG)
K951255 · ERA
Introspect, Inc.
Ear, Nose, Throat · 41d
Cleared Apr 12, 1995
MERCURY
K940081 · DRT
Mennen Medical, Inc.
Cardiovascular · 460d
Cleared Apr 12, 1995
ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE...
K940323 · DSA
Arbo Medical, Inc.
Cardiovascular · 443d
Cleared Apr 12, 1995
MODEL 3470 X-TREL RF RECEIVER
K943537 · GZB
Medtronic Vascular
Neurology · 264d
Cleared Apr 12, 1995
BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER
K945130 · DSH
Braemar Corp.
Cardiovascular · 175d
Cleared Apr 12, 1995
TS-700P CONTROL XP ELECTRICAL STIMULATOR
K945292 · KPI
Myo/Kinetic Systems, Inc.
Gastroenterology & Urology · 163d
Cleared Apr 12, 1995
ECHO PLANAR IMAGING I
K945828 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 134d
Cleared Apr 12, 1995
DASHER-14
K950069 · DQX
Target Therapeutics
Cardiovascular · 93d
Cleared Apr 12, 1995
HYPERPACS PACS AND TELERAFIOLOGY SYSTEM
K950343 · LMD
Rogan Imaging Corp.
Radiology · 75d
Cleared Apr 12, 1995
IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
K950983 · ERA
Introspect, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 11, 1995
HYS-SURGIFLATOR
K924523 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 945d
Cleared Apr 11, 1995
X-RAY FILM PROCESSOR
K940112 · IXW
Fischer Industries, Inc.
Radiology · 456d
Cleared Apr 11, 1995
BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD
K941435 · GEI
New Eder Corp.
General & Plastic Surgery · 383d
Cleared Apr 11, 1995
LUMIN
K943448 · LKF
Utah Medical Products, Inc.
Obstetrics & Gynecology · 267d
Cleared Apr 11, 1995
VIVAPORE 10
K943965 · JJH
Vivascience, Inc.
Chemistry · 257d
Cleared Apr 11, 1995
VIVAPORE 2
K943966 · JJH
Vivascience, Inc.
Chemistry · 257d
Cleared Apr 11, 1995
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
K944759 · FET
Fujinon, Inc.
Gastroenterology & Urology · 196d
Cleared Apr 11, 1995
RH2000 REAL EAR MEASUREMENT SYSTEM
K945199 · EWO
Madsen Electronics, Inc.
Ear, Nose, Throat · 169d
Cleared Apr 11, 1995
TIELLE* HYDROPOLYMER DRESSING
K946245 · KMF
Johnson & Johnson International
General & Plastic Surgery · 110d
Cleared Apr 11, 1995
ENDOSCOPIC BILIARY CATHETER
K946358 · LQR
Boston Scientific Corp
Gastroenterology & Urology · 102d
Cleared Apr 11, 1995
DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET
K950469 · JJY
Casco Standards
Chemistry · 67d