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
50953–50976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2010
AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS
K093773 · FPA
Amsino International, Inc.
General Hospital · 92d
Cleared Mar 10, 2010
TC PLATING SYSTEM
K094037 · HRS
Ortho-Pro, LLC
Orthopedic · 70d
Cleared Mar 10, 2010
MATTIOLI PULSE TWO/THREE PLUS FAMILY
K100053 · ONF
Mattioli Engineering Corp.
General & Plastic Surgery · 61d
Cleared Mar 10, 2010
XVI R4.5
K100115 · IYE
Elekta , Ltd.
Radiology · 54d
Cleared Mar 10, 2010
ENDOCLEAR SYSTEM
K100346 · GCJ
Virtual Ports, Ltd.
General & Plastic Surgery · 26d
Cleared Mar 10, 2010
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE...
K100506 · GAT
Teleflex Medical
General & Plastic Surgery · 16d
Cleared Mar 09, 2010
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K082855 · MRC
Menicon Co, Ltd.
Ophthalmic · 526d
Cleared Mar 09, 2010
VERSEO AIR PRESSURE MASSAGER
K092435 · IRP
The American Export Group &...
Physical Medicine · 214d
Cleared Mar 09, 2010
POC-AS10 AUTO SAMPLER
K092817 · MSQ
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 176d
Cleared Mar 09, 2010
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
K093629 · OVD
Biomet Spine
Orthopedic · 106d
Cleared Mar 09, 2010
SYNTHES MATRIX MIS RODS
K093668 · NKB
Synthes (Usa)
Orthopedic · 102d
Cleared Mar 09, 2010
CLEARPATH UGI
K093779 · FDS
Easyglide , Ltd.
Gastroenterology & Urology · 90d
Cleared Mar 09, 2010
E1 ANTIOXIDANT INFUSED TECHNOLOGY
K100048 · OIY
Biomet Manufacturing Corp
Orthopedic · 60d
Cleared Mar 09, 2010
PSL CLASSIC SLIT LAMP
K100500 · HJO
Keeler Instruments, Inc.
Ophthalmic · 15d
Cleared Mar 08, 2010
MICROCYN SKIN AND WOUND HYDROGEL
K093585 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 109d
Cleared Mar 08, 2010
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
K093788 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 89d
Cleared Mar 08, 2010
DX SERIES FINGER SENSOR
K100020 · DQA
Dixtal Medical, Inc.
Anesthesiology · 62d
Cleared Mar 05, 2010
STEREOS WORKSTATION
K090050 · LLZ
Biospace Med
Radiology · 422d
Cleared Mar 05, 2010
NEONATAL BIOTINIDASE KIT, MODEL 3018
K090123 · NAK
Perkinelmer, Inc.
Chemistry · 408d
Cleared Mar 05, 2010
THERATEST EL-ANTI-CCP/2
K090753 · NHX
Theratest Laboratories, Inc.
Immunology · 350d
Cleared Mar 05, 2010
CHESAPEAKE SPINAL SYSTEM
K092211 · OVD
K2m, Inc.
Orthopedic · 226d
Cleared Mar 05, 2010
SMOOTHCOOL
K092326 · ONF
Jeisys Medical, Inc.
General & Plastic Surgery · 213d
Cleared Mar 05, 2010
P-ART, MODEL 001
K092424 · IYE
P-Cure, Ltd.
Radiology · 210d
Cleared Mar 05, 2010
STAR-LITE -LM, MODEL SL8809
K092460 · OHS
Ps Advanced Engineering
General & Plastic Surgery · 206d