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
79465–79488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2001
CYPRESS SYSTEM
K010950 · IYO
Acuson Corp.
Radiology · 90d
Cleared Jun 27, 2001
A-LINE AEP MONITOR
K010965 · OLW
Alaris Medical Systems, Inc.
Neurology · 86d
Cleared Jun 27, 2001
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
K010998 · HKX
Langham Ophthalmic Technologies
Ophthalmic · 85d
Cleared Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · KTT
Synthes (Usa)
Orthopedic · 83d
Cleared Jun 27, 2001
EASYBELL
K011075 · FCG
Biopsybell S.A.S.
Gastroenterology & Urology · 79d
Cleared Jun 27, 2001
CT/MASTER, VERSION 1.0
K011180 · JAK
Columbia Scientific, Inc.
Radiology · 71d
Cleared Jun 27, 2001
RESTORE-PF VIC
K011295 · EBF
First Scientific Limited
Dental · 58d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · MAI
Smith & Nephew, Inc.
Orthopedic · 58d
Cleared Jun 27, 2001
MODIFICATION TO EXCITE
K011490 · KLE
Ivoclar North America, Inc.
Dental · 43d
Cleared Jun 27, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K011697 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Jun 27, 2001
NPAC EAR THERMOMETER MODEL TD 402
K011704 · FLL
Norm Pacific Automation Corp.
General Hospital · 26d
Cleared Jun 27, 2001
KEYST0NE MEDICAL PICC CATHETER
K011860 · FOZ
Keystone Medical
General Hospital · 13d
Cleared Jun 26, 2001
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
K003927 · BTM
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 188d
Cleared Jun 26, 2001
SYNGO MULTIMODALITY WORKSTATION
K010938 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Jun 26, 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · HOZ
Medtronic Xomed, Inc.
Ophthalmic · 68d
Cleared Jun 26, 2001
MANAN SPRITACRE SPINAL NEEDLES
K011209 · BSP
Manan Medical Products, Inc.
Anesthesiology · 68d
Cleared Jun 26, 2001
HARD RELINER
K011277 · EBI
S & C Polymer GmbH
Dental · 61d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 26, 2001
PARA 5X
K011410 · JPK
Streck Laboratories, Inc.
Hematology · 49d
Cleared Jun 26, 2001
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,...
K011542 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 39d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · MIX
Biomet, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
K011579 · JJY
Bio-Rad
Immunology · 35d
Cleared Jun 26, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH...
K011670 · DQA
Datex-Ohmeda
Anesthesiology · 27d
Cleared Jun 25, 2001
SAVINA
K003068 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 266d