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

Filters: Cleared only ×
176,076 results
59185–59208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2007
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
K071585 · NHA
Straumann USA
Dental · 30d
Cleared Jul 11, 2007
EASYGUIDE
K071599 · LLZ
Keystone Dental, Inc.
Radiology · 30d
Cleared Jul 11, 2007
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · FMF
Terumo Medical Corp.
General Hospital · 27d
Cleared Jul 11, 2007
M2 MONITOR
K071725 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 16d
Cleared Jul 10, 2007
HIGHPAK-12
K062331 · MPD
Ad Elektronik GmbH
Cardiovascular · 334d
Cleared Jul 10, 2007
FACIAL RECONSTRUCTIVE MESH (FRM)
K063154 · FTL
Evera Medical, Inc.
General & Plastic Surgery · 267d
Cleared Jul 10, 2007
MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
K063357 · JKA
Greiner Bio-One North America, Inc.
Hematology · 245d
Cleared Jul 10, 2007
EXPEDIUM SPINE SYSTEM
K063772 · NKB
Depuy Spine, Inc.
Orthopedic · 201d
Cleared Jul 10, 2007
BENVENUE VCF OSTEO COIL SYSTEM
K070293 · OCJ
Benvenue Medical, Inc.
Orthopedic · 160d
Cleared Jul 10, 2007
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
K070333 · FRO
Acrymed, Inc.
General & Plastic Surgery · 155d
Cleared Jul 10, 2007
ATLANTIK
K070794 · MQV
Medical Biomat
Orthopedic · 110d
Cleared Jul 10, 2007
VPAP AUTO WITH H3I
K071171 · BZD
Resmed, Ltd.
Anesthesiology · 74d
Cleared Jul 10, 2007
PARIETEX POLYESTER MESH WITH INTRODUCER
K071629 · FTL
Sofradim Production
General & Plastic Surgery · 26d
Cleared Jul 09, 2007
BCI AUTOCON 3304 DIGITAL PULSE OXIMETER
K070732 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 116d
Cleared Jul 09, 2007
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
K071264 · HRS
Synthes (Usa)
Orthopedic · 66d
Cleared Jul 09, 2007
BIOMET VISION FOOTRING SYSTEM
K071395 · KTT
Biomet Manufacturing Corp
Orthopedic · 49d
Cleared Jul 09, 2007
FL BOND II
K071452 · KLE
Shofu Dental Corp.
Dental · 45d
Cleared Jul 09, 2007
CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
K071534 · MOS
Confirma, Inc.
Radiology · 34d
Cleared Jul 09, 2007
QWIX POSITIONING SCREW
K071639 · HWC
Newdeal Sas
Orthopedic · 24d
Cleared Jul 08, 2007
HEXAPOD RT COUCH TOP
K071870 · JAI
Medical Intelligence Medizintechnik GmbH
Radiology · 2d
Cleared Jul 06, 2007
WELLNESSPRO 2010
K062616 · GZJ
Intelsource Group, Inc.
Neurology · 304d
Cleared Jul 06, 2007
SAPIMED DISPOSABLE SIGMOIDOSCOPE
K070915 · KDM
Sapimed S.P.A.
Gastroenterology & Urology · 95d
Cleared Jul 06, 2007
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K071107 · MBH
Zimmer, Inc.
Orthopedic · 78d
Cleared Jul 06, 2007
MODIFICATION TO: STOCKERT S5 SYSTEM
K071318 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 57d