Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
43801–43824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2012
MERIDIAN CRANIAL PERFORATOR
K121253 · HBF
Adeor Medical Technologies GmbH
Neurology · 83d
Cleared Jul 17, 2012
NON-CONTACT CLINICAL THERMOMETER
K121428 · FLL
Radiant Innovation, Inc.
General Hospital · 64d
Cleared Jul 17, 2012
A&J 5L POCA SERIES OXYGEN CONCENTRATOR
K121531 · CAW
Zhongshan A&J Medical Equipment Co.,...
Anesthesiology · 54d
Cleared Jul 17, 2012
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K121832 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 17, 2012
NMI MICROCATHETER
K121954 · DQO
Navilyst Medical, Inc.
Cardiovascular · 14d
Cleared Jul 16, 2012
CARDIO 7
K113306 · DPS
Bionet Co., Ltd.
Cardiovascular · 250d
Cleared Jul 16, 2012
HEARTRAIL III GUIDING CATHETER
K113335 · DQO
Terumo Corporation
Cardiovascular · 245d
Cleared Jul 16, 2012
VIGNET TELEHEALTH MANAGER
K113446 · DRG
Vignet, Inc.
Cardiovascular · 238d
Cleared Jul 16, 2012
3MP COLOR LCD MONITOR, RADIFORCE RX340
K113562 · LLZ
Eizo Nanao Corporation
Radiology · 228d
Cleared Jul 16, 2012
ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
K120253 · DRG
Elcam Medical Acal
Cardiovascular · 171d
Cleared Jul 16, 2012
CALYPSO SYSTEM
K120564 · NKB
Hogan Lovells US LLP
Orthopedic · 143d
Cleared Jul 16, 2012
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK...
K120920 · BZD
Hsiner Company
Anesthesiology · 111d
Cleared Jul 16, 2012
MAGNETOM SPECTRA
K121160 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jul 16, 2012
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
K121474 · GDW
Changzhou Kangdi Medical Stapler Co.,...
General & Plastic Surgery · 59d
Cleared Jul 16, 2012
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
K121600 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 45d
Cleared Jul 16, 2012
OSTOMY IRRIGATION SET
K121833 · EXD
Coloplast A/S
Gastroenterology & Urology · 24d
Cleared Jul 16, 2012
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
K121837 · KWQ
Nuvasive, Inc.
Orthopedic · 24d
Cleared Jul 13, 2012
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
K111014 · HEW
Lsi Solutions, Inc.
Obstetrics & Gynecology · 459d
Cleared Jul 13, 2012
MONICA AN24
K112390 · OSP
Monica Healthcare, Ltd.
Obstetrics & Gynecology · 330d
Cleared Jul 13, 2012
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
K112413 · MQK
Research Instruments , Ltd.
Obstetrics & Gynecology · 326d
Cleared Jul 13, 2012
CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR
K112840 · CCK
Seebreath AB
Anesthesiology · 288d
Cleared Jul 13, 2012
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
K113192 · NBW
Infopia Co, Ltd.
Chemistry · 256d
Cleared Jul 13, 2012
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT...
K113374 · CIX
Alfa Wassermann Diagnostic...
Chemistry · 240d
Cleared Jul 13, 2012
PLANCET
K113513 · FMK
Micropoint Technologies Pte, Ltd.
General & Plastic Surgery · 228d