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

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175,820 results
51265–51288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 2010
JALOSKIN
K092257 · FRO
Fidia Advanced Biopolymers Srl
General & Plastic Surgery · 182d
Cleared Jan 26, 2010
RESPISENS
K092845 · IYE
Nomics
Radiology · 133d
Cleared Jan 26, 2010
DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
K093070 · MNS
Sunrise Medical
Anesthesiology · 118d
Cleared Jan 26, 2010
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363 · MBL
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jan 26, 2010
MERIDIAN GUIDEWIRE
K093681 · DQX
Ev3 Neurovascular
Cardiovascular · 60d
Cleared Jan 26, 2010
ATRIUM C-QUR OVT MESH
K100076 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 14d
Cleared Jan 25, 2010
ANY PLUS SPINAL FIXATION SYSTEM
K091717 · NKB
GS Medical Co., Ltd.
Orthopedic · 228d
Cleared Jan 25, 2010
U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR,...
K092106 · DXN
Taidoc Technology Corporation
Cardiovascular · 195d
Cleared Jan 25, 2010
TIGR SURGICAL MESH , MODEL WK-6
K092224 · FTL
Novus Scientific Pte, Ltd.
General & Plastic Surgery · 186d
Cleared Jan 25, 2010
SOLO MICROPUMP INSULIN DELIVERY SYSTEM
K093364 · LZG
Medingo , Ltd.
General Hospital · 89d
Cleared Jan 25, 2010
RAPIDSORB PLUS SCREW SYSTEM
K093464 · DZL
Synthes (Usa)
Dental · 80d
Cleared Jan 25, 2010
GRIND NO MORE GENERATION II
K094020 · OBR
Ranir, LLC
Dental · 27d
Cleared Jan 25, 2010
TURBO-TANDEM SYSTEM MODEL 472-110
K094036 · MCW
Spectranetics Corp.
Cardiovascular · 26d
Cleared Jan 22, 2010
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
K091328 · JXG
Sophysa SA
Neurology · 262d
Cleared Jan 22, 2010
BTI DENTAL IMPLANT 5.5-6.5
K091387 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 256d
Cleared Jan 22, 2010
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
K092098 · LPH
Smith & Nephew, Inc.
Orthopedic · 192d
Cleared Jan 22, 2010
ACP4 SPINAL IMPLANT SYSTEM
K092360 · KWQ
X-Spine Systems, Inc.
Orthopedic · 171d
Cleared Jan 22, 2010
LAPAROSCOPIC RETRACTORS
K092684 · GCJ
Cardinal Health, Inc.
General & Plastic Surgery · 143d
Cleared Jan 22, 2010
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K092818 · MNS
Respironics, Inc.
Anesthesiology · 130d
Cleared Jan 22, 2010
METAPHOR METABOLIC MONITOR
K093080 · BZL
Treymed, Inc.
Anesthesiology · 114d
Cleared Jan 22, 2010
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT...
K093162 · GEX
Fotona D.D.
General & Plastic Surgery · 108d
Cleared Jan 22, 2010
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
K093185 · GXD
Diros Technology, Inc.
Neurology · 105d
Cleared Jan 22, 2010
MODIFIED: NEWDEAL HALLU PLATES
K093781 · HRS
Newdeal Sas
Orthopedic · 44d
Cleared Jan 22, 2010
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC...
K093823 · DXN
Health & Life Co., Ltd.
Cardiovascular · 39d