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

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175,820 results
38761–38784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2014
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
K133401 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Mar 11, 2014
BONE SUPPRESSION SOFTWARE
K133442 · MQB
Carestream Health, Inc.
Radiology · 119d
Cleared Mar 11, 2014
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR...
K133483 · IRP
Portable Therapeutix
Physical Medicine · 118d
Cleared Mar 11, 2014
KOWA SL-17
K133755 · HJO
Kowa Co. , Ltd.
Ophthalmic · 92d
Cleared Mar 11, 2014
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
K140248 · KHS
Hitachi Chemical Diagnostics, Inc.
Chemistry · 40d
Cleared Mar 11, 2014
ULTIMUM EV HEMOSTASIS INTRODUCER
K140327 · DYB
St Jude Medical
Cardiovascular · 29d
Cleared Mar 10, 2014
BIOFUSIONARY BEBE
K121123 · IMJ
Rocky Mountain Biosystems, Inc.
Physical Medicine · 696d
Cleared Mar 10, 2014
T4/T5 HYTREL TOGAS
K121664 · FYA
Stryker Corporation
General Hospital · 643d
Cleared Mar 10, 2014
MM-SEAL
K123276 · KIF
Micro-Mega Societe Anonyme
Dental · 507d
Cleared Mar 10, 2014
BWCSH-1 SHARPS CONTAINER
K131708 · MMK
Bradford Wright Companies, Inc.
General Hospital · 272d
Cleared Mar 10, 2014
NEWTRON P5, NEWTRON P5 B.LED
K132267 · ELC
Satelec - Acteon Group
Dental · 231d
Cleared Mar 10, 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 171d
Cleared Mar 10, 2014
VAN HIP FRACTURE SYSTEM
K133104 · HSB
Epix Orthopaedic, Corp.
Orthopedic · 161d
Cleared Mar 10, 2014
IMPACT MODEL 323 ASPIRATOR
K133196 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 144d
Cleared Mar 10, 2014
ACUMED SUTURE ANCHOR SYSTEM
K133469 · MBI
Acumed, LLC
Orthopedic · 118d
Cleared Mar 10, 2014
DERMABOND PRINEO SKIN CLOSURE SYSTEM
K133864 · OMD
Ethicon, Inc.
General & Plastic Surgery · 81d
Cleared Mar 10, 2014
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN...
K140267 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 10, 2014
CMC MINI TIGHTROPE
K140328 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Mar 07, 2014
HEINE MINI 3000(R) OPHTHALMOSCOPE
K131959 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 253d
Cleared Mar 07, 2014
MALE LATEX CONDOM
K132107 · HIS
Nulatex Sdn. Bhd.
Obstetrics & Gynecology · 242d
Cleared Mar 07, 2014
CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL...
K132945 · HSB
I.T.S. GmbH
Orthopedic · 169d
Cleared Mar 07, 2014
IMPAX VOLUME VIEWING 3.0
K133135 · LLZ
Agfa Healthcare N.V.
Radiology · 154d
Cleared Mar 07, 2014
BLACKBIRD SPINAL SYSTEM
K133214 · KWP
Choicespine, LP
Orthopedic · 140d
Cleared Mar 07, 2014
INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
K133363 · PEK
Ldr Spine USA, Inc.
Orthopedic · 126d