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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
65353–65376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2005
BIOPAD
K040283 · QSY
Euroresearch Srl
General & Plastic Surgery · 532d
Cleared Jul 22, 2005
AFINION HBALC
K050574 · LCP
Axis-Shield Poc AS
Chemistry · 137d
Cleared Jul 22, 2005
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K051180 · KTT
Vanguard Medical Concepts, Inc.
Orthopedic · 74d
Cleared Jul 22, 2005
ZIROX
K051249 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 67d
Cleared Jul 22, 2005
NITRILE EXAMINATION GLOVES, POWDER FREE
K051333 · LZA
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 60d
Cleared Jul 22, 2005
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K051365 · CAF
K-Jump Health Co., Ltd.
Anesthesiology · 58d
Cleared Jul 22, 2005
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO
K051443 · LYC
Curasan Ag, Frankfurt Facility
Dental · 50d
Cleared Jul 22, 2005
VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT
K051627 · GEI
Valleylab
General & Plastic Surgery · 32d
Cleared Jul 22, 2005
ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT
K051652 · NHA
Atlantis Components, Inc.
Dental · 31d
Cleared Jul 22, 2005
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
K051662 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 30d
Cleared Jul 22, 2005
EQUA-PULL SAFETY RELEASE MODULE
K051751 · DZB
Ortho Technology
Dental · 23d
Cleared Jul 21, 2005
TURBO-FLO PICC
K041849 · LJS
Cook, Inc.
General Hospital · 378d
Cleared Jul 21, 2005
MIRAMATIC SAFE SYRINGE SYSTEM
K043322 · EJI
Hager Worldwide, Inc.
Dental · 231d
Cleared Jul 21, 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391 · KWP
Globus Medical, Inc.
Orthopedic · 155d
Cleared Jul 21, 2005
OSCAR, MODEL OE3000DB
K051053 · JDX
Orthosonics, Ltd.
Orthopedic · 87d
Cleared Jul 21, 2005
CELL-DYN SAPPHIRE SYSTEM
K051215 · GKZ
Abbott Laboratories
Hematology · 70d
Cleared Jul 21, 2005
SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
K051256 · ISH
Noble Fiber Technologies, Inc.
Physical Medicine · 66d
Cleared Jul 21, 2005
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
K051410 · HRS
Acumed, LLC
Orthopedic · 51d
Cleared Jul 21, 2005
AVANTICARE, MODEL SA4022
K051538 · INI
Lerado China Limited
Physical Medicine · 41d
Cleared Jul 21, 2005
CD HORIZON SPINAL SYSTEM
K051674 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jul 21, 2005
FUTURE WASH/YPS
K051797 · ELW
3M Espe AG Dental Products
Dental · 16d
Cleared Jul 20, 2005
REPROCESSED COLD BIOPSY FORCEPS
K042648 · NON
Sterilmed, Inc.
Gastroenterology & Urology · 295d
Cleared Jul 20, 2005
REPROCESSED HOT BIOPSY FORCEPS
K050136 · NLU
Sterilmed, Inc.
Gastroenterology & Urology · 180d
Cleared Jul 20, 2005
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
K051229 · JWH
Smith & Nephew, Inc.
Orthopedic · 68d