FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
121513–121536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 1991
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K911286 · DYH
Pulpdent Corp.
Dental · 108d
Cleared Jul 05, 1991
HARDING STERNAL SHIELD
K911407 · EYF
Harding Medical Devices
General & Plastic Surgery · 98d
Cleared Jul 05, 1991
MAGNUM-MEIER RECANALIZATION GUIDEWIRE
K911547 · DQX
Schneider Intl., Ltd.
Cardiovascular · 88d
Cleared Jul 05, 1991
ZEPHYR INFUSION CATHETER
K911560 · DQO
Target Therapeutics
Cardiovascular · 88d
Cleared Jul 05, 1991
CHEMOTHERAPY CONTAINER
K911576 · KPE
Bemis Mfg. Co.
General Hospital · 88d
Cleared Jul 05, 1991
DISPOSABLE SURGICAL TROCAR WITH SEAL
K911589 · GCJ
Applied Vascular Devices, Inc.
General & Plastic Surgery · 87d
Cleared Jul 05, 1991
INNOFLUOR(TM) VALPROIC ACID REAGENT SET
K911688 · LEG
Intl. Bioclinical, Inc.
Toxicology · 80d
Cleared Jul 05, 1991
ACCU-VENT(TM) WITH NEEDLE-PRO(TM)
K912043 · CBT
Concord/Portex
Anesthesiology · 58d
Cleared Jul 04, 1991
HH-1119 HEALING HEAD
K903515 · DZE
Minimatic Implant Technology
Dental · 335d
Cleared Jul 03, 1991
COLOCARE
K905798 · KHE
Helena Laboratories
Hematology · 226d
Cleared Jul 03, 1991
NEUROCAM
K910967 · IYX
GE Medical Systems
Radiology · 119d
Cleared Jul 03, 1991
COLOSCREEN
K911075 · KHE
Helena Laboratories
Hematology · 114d
Cleared Jul 03, 1991
PHILIPS URO DIAGNOST MRF
K911098 · IXR
Philips Medical Systems, Inc.
Radiology · 113d
Cleared Jul 03, 1991
ALL-PRO 100
K911291 · IXW
All-Pro Imaging Corp.
Radiology · 100d
Cleared Jul 03, 1991
LAPAROSCOPIC FORCEPS
K911474 · HCZ
United States Endoscopy Group, Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 03, 1991
ORALCAM
K911594 · EIA
Charmac Group, Inc.
Dental · 85d
Cleared Jul 03, 1991
MEDX MACHINE
K911666 · IKK
Medx Corp.
Physical Medicine · 82d
Cleared Jul 03, 1991
COIL FIELD EXTENDER
K911800 · LNH
Resonex, Inc.
Radiology · 71d
Cleared Jul 03, 1991
KIN-COM ASYMMETRICAL BACK SYSTEM
K911805 · IKK
Chattanooga Group, Inc.
Physical Medicine · 71d
Cleared Jul 02, 1991
LAPAROMED HOOK/SPATULA DEVICE
K910074 · GEI
Laparomed Corp.
General & Plastic Surgery · 175d
Cleared Jul 02, 1991
ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705
K911272 · FHG
Edward Weck, Inc.
Obstetrics & Gynecology · 102d
Cleared Jul 02, 1991
LAPAROSCOPIC VESSEL ARTICULATOR
K911475 · DWP
United States Endoscopy Group, Inc.
Cardiovascular · 89d
Cleared Jul 02, 1991
LAPAROSCOPIC ELECTRODE WITH LAVAGE AND SUCTION
K911476 · GEI
United States Endoscopy Group, Inc.
General & Plastic Surgery · 89d
Cleared Jul 02, 1991
LAPAROSCOPIC TROCAR
K911483 · DRC
United States Endoscopy Group, Inc.
Cardiovascular · 89d