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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37633–37656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
K140060 · MQB
Rayence Co., Ltd.
Radiology · 123d
Cleared May 13, 2014
IMDX HSV-1/2 FOR ABBOTT M2000
K140198 · OQO
Intelligent Medical Devices, Inc.
Microbiology · 106d
Cleared May 13, 2014
AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN,...
K140343 · MPN
Aesculap, Inc.
General & Plastic Surgery · 91d
Cleared May 13, 2014
VITREA IMAGE DENOISING SOFTWARE
K140395 · LLZ
Vital Images, Inc.
Radiology · 84d
Cleared May 13, 2014
CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT
K140568 · FMI
Facet Technologies, LLC
General Hospital · 69d
Cleared May 13, 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622 · HRS
Biomet, Inc.
Orthopedic · 63d
Cleared May 13, 2014
ONE-PIECE PEEK FUSION IMPLANT
K140970 · HWC
Mtp Solutions, LLC
Orthopedic · 27d
Cleared May 12, 2014
ROSS RU SKIN DISCONTINUITIES
K131176 · FRO
Biotd S.A.
General & Plastic Surgery · 382d
Cleared May 12, 2014
TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT...
K131531 · MEG
Anhui Tiankang Medical Products Co.,...
General Hospital · 349d
Cleared May 12, 2014
GALLIEON-1 MEDICAL LASER
K132529 · ILY
Future Device and Technology, Inc.
Physical Medicine · 273d
Cleared May 12, 2014
AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
K132686 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 257d
Cleared May 12, 2014
ENDOCEM ZR
K133042 · KIF
Maruchi
Dental · 227d
Cleared May 12, 2014
ENDOSEAL
K133054 · KIF
Maruchi
Dental · 227d
Cleared May 12, 2014
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K133378 · PHX
Zimmer, Inc.
Orthopedic · 189d
Cleared May 12, 2014
ZERONA
K133718 · OLI
Erchonia Corporation
General & Plastic Surgery · 159d
Cleared May 12, 2014
S9 ELOUERA
K140124 · BZD
ResMed Corp
Anesthesiology · 116d
Cleared May 12, 2014
SUPERCATH5
K140419 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 83d
Cleared May 12, 2014
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
K140606 · MOS
Resonance Innovations, LLC
Radiology · 63d
Cleared May 09, 2014
DUET SYSTEM
K130775 · NTH
Bioview , Ltd.
Pathology · 415d
Cleared May 09, 2014
RITTER IMPLANT SYSTEM
K131557 · DZE
Ritter Implants GmbH CO KG
Dental · 345d
Cleared May 09, 2014
YZ3 PORTABLE SLIT LAMP
K131711 · HJO
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 332d
Cleared May 09, 2014
A9800 ANESTHESIA WORKSTATION
K131790 · BSZ
Oricare, Inc.
Anesthesiology · 325d
Cleared May 09, 2014
SINGLE-SITE PORT
K133203 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 204d
Cleared May 09, 2014
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K133251 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 199d