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
37657–37680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2014
LEKSELL GAMMA KNIFE PERFEXION
K133565 · IWB
Elekta Instrument AB
Radiology · 170d
Cleared May 09, 2014
ADX4000W
K134055 · MUH
Dexcowin Co., Ltd.
Radiology · 129d
Cleared May 09, 2014
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
K140122 · GEX
Candela Corp.
General & Plastic Surgery · 113d
Cleared May 09, 2014
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
K140354 · LSL
Abbott Molecular, Inc.
Microbiology · 86d
Cleared May 08, 2014
MRNA APPLIANCE
K130067 · LRK
Biomodeling Solutions, Lls
Dental · 483d
Cleared May 08, 2014
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
K132711 · LBS
Carolina Liquid Chemistries Corp.
Chemistry · 252d
Cleared May 08, 2014
STALIF C(R)
K133200 · OVE
Centinel Spine, Inc.
Orthopedic · 203d
Cleared May 08, 2014
ASTHMA MONITOR AM3
K133722 · BZG
Eresearch Technology
Anesthesiology · 154d
Cleared May 08, 2014
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · DZE
Nobel Biocare AB
Dental · 153d
Cleared May 08, 2014
SCINTILLATION GAMMA CAMERA
K140206 · KPS
Ddd-Diagnostic A/S
Radiology · 101d
Cleared May 08, 2014
16 CH MULTIPURPOSE COIL VARIETY
K140252 · MOS
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 97d
Cleared May 08, 2014
HERMES MEDICAL IMAGING SUITE V5.4
K140269 · KPS
Hermes Medical Solutions AB
Radiology · 94d
Cleared May 08, 2014
ELECSYS CK-MB STAT IMMUNOASSAY
K140404 · JHY
Roche Diagnostics
Chemistry · 79d
Cleared May 08, 2014
AAP LOQTEC(R) OLECRANON PLATE
K140607 · HRS
Aap Implantate AG
Orthopedic · 59d
Cleared May 08, 2014
ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
K140755 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 43d
Cleared May 08, 2014
FILTEK BULK FILL POSTERIOR RESTROATIVE
K141081 · EBF
3M Espe Dental Products
Dental · 13d
Cleared May 07, 2014
GORE BIO-A WOUND MATRIX
K132397 · QSZ
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 279d
Cleared May 07, 2014
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
K132475 · OWN
Fluoptics
General & Plastic Surgery · 273d
Cleared May 07, 2014
Origio Gas Line Filter
K132870 · MQG
Origio, Inc.
Obstetrics & Gynecology · 236d
Cleared May 07, 2014
TRUE SPINAL FUSSION SYSTEM
K133690 · MNH
Innovative Surgical Designs
Orthopedic · 156d
Cleared May 07, 2014
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
K133801 · FRN
Baxter Healthcare Corporation
General Hospital · 145d
Cleared May 07, 2014
LUXER SHADED ZIRCONIA
K140070 · EIH
Continental Dental Ceramics, Inc.
Dental · 114d
Cleared May 07, 2014
EXCELLA III-D SPINAL DEFORMITY SYSTEM
K140238 · NKB
Innovasis, Inc.
Orthopedic · 97d
Cleared May 07, 2014
CARESITE LUER ACCESS DEVICE
K140311 · FPA
B.Braun Medical, Inc.
General Hospital · 89d