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
56137–56160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2008
ORTHOMESH
K073115 · HRS
Synthes (Usa)
Orthopedic · 253d
Cleared Jul 15, 2008
SCREWINDIRECT DENTAL IMPLANTS
K080633 · DZE
Implant Direct, LLC
Dental · 132d
Cleared Jul 15, 2008
VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K080897 · OMP
Talley Medical
General & Plastic Surgery · 106d
Cleared Jul 15, 2008
ULTRASHARP CONCENTRIC NEEDLES
K080914 · IKT
Rochester Electro Medical, Inc.
Neurology · 105d
Cleared Jul 15, 2008
FENCER 308 EXCIMER LASER SYSTEM
K080975 · GEX
Kera Harvest/Laser Max Medical...
General & Plastic Surgery · 99d
Cleared Jul 15, 2008
NT/IT SYSTEM
K081078 · DZE
Osstem Implant Co., Ltd.
Dental · 90d
Cleared Jul 15, 2008
TEPHAFLEX ABSORBABLE SUTURE
K081099 · NWJ
Tepha, Inc.
General & Plastic Surgery · 89d
Cleared Jul 15, 2008
KUMAR T-ANCHORS HERNIA SET
K081366 · GAR
Nashville Surgical Instruments
General & Plastic Surgery · 61d
Cleared Jul 15, 2008
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K081389 · NBW
Roche Diagnostics
Chemistry · 57d
Cleared Jul 15, 2008
MAC 1600 ECG ANALYSIS SYSTEM
K081437 · DPS
Ge Medical Systems Information...
Cardiovascular · 54d
Cleared Jul 15, 2008
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
K081843 · LLZ
Aloka Co., Ltd.
Radiology · 15d
Cleared Jul 15, 2008
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
K081905 · MEB
Westmed, Inc.
General Hospital · 12d
Cleared Jul 14, 2008
S40 CLINICAL ANALYZER, S TEST ALB
K072143 · CIX
Alfa Wassermann Diagnostic...
Chemistry · 347d
Cleared Jul 14, 2008
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
K072291 · HWC
Conmed Linvatec
Orthopedic · 333d
Cleared Jul 14, 2008
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
K080982 · LIT
Boston Scientific Corp
Cardiovascular · 98d
Cleared Jul 14, 2008
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH...
K081089 · LZC
Kimberly-Clark Corp.
General Hospital · 89d
Cleared Jul 14, 2008
MONOPOLY PEDICLE SCREW SYSTEM
K081108 · NKB
Signus Medical, LLC
Orthopedic · 87d
Cleared Jul 14, 2008
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
K081132 · KWQ
Spine Smith Partners L.P.
Orthopedic · 84d
Cleared Jul 14, 2008
TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE
K081188 · IYE
Varian Medical Systems, Inc.
Radiology · 77d
Cleared Jul 14, 2008
GN OTOMETRICS INSERT EARPHONES
K081234 · EWO
Gn Otometrics
Ear, Nose, Throat · 74d
Cleared Jul 14, 2008
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
K081418 · KWQ
Spinal Elements, Inc.
Orthopedic · 55d
Cleared Jul 14, 2008
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K081690 · FOZ
Cook, Inc.
General Hospital · 27d
Cleared Jul 11, 2008
SRT II MUSCLE STIMULATOR
K071677 · IPF
Therapeutic Innovations, Inc.
Physical Medicine · 388d
Cleared Jul 11, 2008
INION SPINAL GRAFT CONTAINMENT SYSTEM
K071810 · OJB
Inion , Ltd.
Orthopedic · 375d