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
42817–42840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2012
REGEN SPRAY APPLICATOR,
K122122 · FMF
Regen Lab SA
General Hospital · 115d
Cleared Nov 09, 2012
AIR-BAND RADIAL COMPRESSION DEVICE
K122405 · DXC
Datascope Corp., Cardiac Assist Division
Cardiovascular · 94d
Cleared Nov 09, 2012
AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700
K122580 · GEI
Encision, Inc.
General & Plastic Surgery · 78d
Cleared Nov 09, 2012
PERSONA NATURAL TIBIA BASEPLATES
K122765 · JWH
Zimmer, Inc.
Orthopedic · 60d
Cleared Nov 08, 2012
CORVIS ST
K113066 · HKX
Oculus Optikgerate GmbH
Ophthalmic · 388d
Cleared Nov 08, 2012
DCS LACRIMAL STENT
K113316 · OKS
Dcs Surgical, Inc.
Ophthalmic · 365d
Cleared Nov 08, 2012
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601 · HRS
Aap Implantate AG
Orthopedic · 339d
Cleared Nov 08, 2012
MTF FASCIA
K120479 · OWY
Musculoskeletal Transplant Foundation
Orthopedic · 266d
Cleared Nov 08, 2012
ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
K120873 · NHA
Zimmer Dental, Inc.
Dental · 231d
Cleared Nov 08, 2012
TERUMO(R) NEEDLE
K121607 · FMI
Terumo (Philippines) Corporation
General Hospital · 160d
Cleared Nov 08, 2012
STINGRAY GUIDEWIRES
K122795 · DQX
Bridgepoint Medical
Cardiovascular · 57d
Cleared Nov 07, 2012
COMEN MULTI-PARAMETER PATIENT MONITOR
K112877 · MWI
Goldway Us, Inc.
Cardiovascular · 404d
Cleared Nov 07, 2012
CLEARLUMEN THROMBECTOMY SYSTEM
K120508 · QEZ
Walk Vascular, LLC
Cardiovascular · 260d
Cleared Nov 07, 2012
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
K121277 · HWC
Z-Medical GmbH & Co. KG
Orthopedic · 194d
Cleared Nov 07, 2012
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
K121725 · KWP
Pioneer Surgical Technology, Inc.
Orthopedic · 148d
Cleared Nov 07, 2012
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
K121771 · MBH
Zimmer, Inc.
Orthopedic · 145d
Cleared Nov 07, 2012
ENCORE TONGUE SUSPENSION SYSTEM
K121814 · ORY
Siesta Medical, Inc.
Dental · 140d
Cleared Nov 07, 2012
BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
K122278 · GEI
Baylis Medical Company, Inc.
General & Plastic Surgery · 100d
Cleared CT Nov 07, 2012
OCELOT SYSTEM
K122380 · PDU
Avinger, Inc.
Cardiovascular · 93d
Cleared Nov 07, 2012
INOBLENDER
K122689 · MRO
Ino Therapeutics
Anesthesiology · 64d
Cleared Nov 07, 2012
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K122738 · HWC
Solana Surgical, LLC
Orthopedic · 62d
Cleared Nov 07, 2012
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL...
K122857 · CAF
Pegasus Research Corp.
Anesthesiology · 50d
Cleared Nov 07, 2012
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
K122912 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 47d
Cleared Nov 07, 2012
HAMMER TOE IMPLANT
K122959 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 43d