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
56833–56856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2008
ZOLL E SERIES 12SL, ANALYSIS OPTION
K080232 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 84d
Cleared Apr 23, 2008
SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
K080248 · GEX
Lutronic Corporation
General & Plastic Surgery · 83d
Cleared Apr 23, 2008
AMBULO 2400
K080274 · DXN
Tiba Medical, Inc.
Cardiovascular · 82d
Cleared Apr 23, 2008
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
K080315 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 77d
Cleared Apr 23, 2008
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K080335 · MBI
Tornier, Inc.
Orthopedic · 76d
Cleared Apr 23, 2008
PLLA, HA SCREW
K080358 · HWC
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 72d
Cleared Apr 23, 2008
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
K080425 · DRF
Biosense Webster, Inc.
Cardiovascular · 68d
Cleared Apr 23, 2008
SEDAT MYSHELL LITE
K080472 · DTL
Sedat
Cardiovascular · 62d
Cleared Apr 23, 2008
CENTURION SORBAVIEW OTC
K080524 · NAD
Tri-State Hospital Supply Corp.
General & Plastic Surgery · 57d
Cleared Apr 23, 2008
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
K080670 · DSK
Atcor Medical
Cardiovascular · 44d
Cleared Apr 23, 2008
TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
K080815 · KWQ
Signus Medizintechnik GmbH
Orthopedic · 30d
Cleared Apr 23, 2008
DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH...
K080918 · NEW
Depuy Mitek
General & Plastic Surgery · 22d
Cleared Apr 23, 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943 · HWC
Synthes (Usa)
Orthopedic · 20d
Cleared Apr 23, 2008
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
K080985 · NEW
Surgical Specialties Corp
General & Plastic Surgery · 16d
Cleared Apr 22, 2008
MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
K072061 · JEH
Viasys Healthcare GmbH
Anesthesiology · 270d
Cleared Apr 22, 2008
SYNGO MULTIMODALITY WORKPLACE
K072728 · LLZ
Siemens AG Medical Solutions
Radiology · 209d
Cleared Apr 22, 2008
ENDOWAVE INFUSION SYSTEM
K073166 · KRA
Ekos Corp.
Cardiovascular · 165d
Cleared Apr 22, 2008
PERIPHERAL NERVE BLOCK SUPPORT TRAY
K073187 · CAZ
Life-Tech, Inc.
Anesthesiology · 161d
Cleared Apr 22, 2008
UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
K080162 · DZE
Mis Implants Technologies , Ltd.
Dental · 90d
Cleared Apr 22, 2008
DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
K080351 · LLZ
Dexela, Ltd.
Radiology · 71d
Cleared Apr 22, 2008
WESTCON HORIZON 49% (HIOXIFILCON B)
K080686 · LPL
Westcon Contact Lens Co.
Ophthalmic · 42d
Cleared Apr 22, 2008
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
K080821 · BTR
Kimberly-Clark Corp.
Anesthesiology · 29d
Cleared Apr 21, 2008
GRAVILAX TRACTION SYSTEM
K072064 · ITH
Therapeutic Clinical Technologies, Inc.
Physical Medicine · 269d
Cleared Apr 21, 2008
DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE...
K072613 · GCJ
Micro Invasive Technology, Inc.
General & Plastic Surgery · 217d