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
111649–111672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1993
MALLAWANY TISSUE GRASPING FORCEPS
K923126 · HET
Numed Technologies, Inc.
Obstetrics & Gynecology · 469d
Cleared Oct 08, 1993
INSUFFLATOR CONNECTING FILTER
K923194 · HIF
Procedure Products, Inc.
Obstetrics & Gynecology · 465d
Cleared Oct 08, 1993
THE MASSAGER
K924315 · LYG
Four Directions
Physical Medicine · 408d
Cleared Oct 08, 1993
VISIDISC KITS, SPINESCOPE
K924720 · GEX
Laserscope
General & Plastic Surgery · 382d
Cleared Oct 08, 1993
BULK TISSUE REMOVAL SYSTEM
K924844 · HET
L.A.S.E.R., Inc.
Obstetrics & Gynecology · 375d
Cleared Oct 08, 1993
FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE
K924996 · KNT
Abbott Laboratories
Gastroenterology & Urology · 372d
Cleared Oct 08, 1993
MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE
K925572 · HGM
Neward Enterprises, Inc.
Obstetrics & Gynecology · 339d
Cleared Oct 08, 1993
ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT
K925627 · IYO
Elscint, Inc.
Radiology · 336d
Cleared Oct 08, 1993
STANDARD
K925752 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 329d
Cleared Oct 08, 1993
UNI III
K925753 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 329d
Cleared Oct 08, 1993
ECONOM
K925754 · EPY
Rudolf Riester GmbH & Co. KG
General & Plastic Surgery · 329d
Cleared Oct 08, 1993
MRT-50A, MRT-150A
K926001 · LNH
Toshiba America Mri, Inc.
Radiology · 315d
Cleared Oct 08, 1993
SILICONE RECTAL BALLOON
K930135 · FEN
Cook Urological, Inc.
Gastroenterology & Urology · 269d
Cleared Oct 08, 1993
APPLIER, SURGICAL, CLIP
K930605 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 245d
Cleared Oct 08, 1993
DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
K931552 · CAC
Davol, Inc.
Anesthesiology · 193d
Cleared Oct 08, 1993
JACE TRI-STIM DEVICE
K931781 · IPF
Jace Systems, Inc.
Physical Medicine · 182d
Cleared Oct 08, 1993
5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES
K931803 · LDD
Zoll Medical Corp
Cardiovascular · 179d
Cleared Oct 08, 1993
ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO
K931804 · LDD
Zoll Medical Corp
Cardiovascular · 179d
Cleared Oct 08, 1993
ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT
K931805 · LDD
Zoll Medical Corp
Cardiovascular · 179d
Cleared Oct 08, 1993
AZ 92
K931974 · IWE
A2j, Inc.
Radiology · 169d
Cleared Oct 08, 1993
PD-1400 PACER/DEFIBRILLATOR
K932028 · MKJ
Zoll Medical Corp
Cardiovascular · 165d
Cleared Oct 08, 1993
RI-MINI
K932503 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 140d
Cleared Oct 08, 1993
RI-STAR
K932505 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 140d
Cleared Oct 08, 1993
RI-SCOPE (S)
K932506 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 140d