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
62209–62232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2006
DEL SOL BLUE LIGHT THERAPY SYSTEM
K061470 · GEX
Edge Systems Corporation
General & Plastic Surgery · 55d
Cleared Jul 19, 2006
TROKAMED GMBH ENDOSCOPES AND ACCESSORIES
K060233 · GCJ
Trokamed GmbH
General & Plastic Surgery · 170d
Cleared Jul 19, 2006
SBI ULNAR HEAD IMPLANT
K061146 · KXE
Small Bone Innovations, Inc.
Orthopedic · 85d
Cleared Jul 19, 2006
MEDLINE SYRINGES, MULTIPLE
K061275 · FMF
Medline Industries, Inc.
General Hospital · 72d
Cleared Jul 19, 2006
KFX KNOTLESS FIXATION SYSTEM
K061294 · MBI
Kfx Medical
Orthopedic · 71d
Cleared Jul 19, 2006
ALLTHREAD LACTOSORB SUTURE ANCHOR
K061389 · JDR
Arthrotek, Inc.
Orthopedic · 62d
Cleared Jul 19, 2006
OPTILENE MESH
K061704 · FTL
Aesculap, Inc.
General & Plastic Surgery · 33d
Cleared Jul 19, 2006
OASIS WOUND MATRIX
K061711 · KGN
Cook Biotech, Inc.
General & Plastic Surgery · 30d
Cleared Jul 19, 2006
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
K061767 · QSY
Z-Medica Corporation
General & Plastic Surgery · 26d
Cleared Jul 19, 2006
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
K061909 · GEX
Omniguide, Inc.
General & Plastic Surgery · 13d
Cleared Jul 18, 2006
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K052407 · JZO
Fisher Diagnostics
Immunology · 320d
Cleared Jul 18, 2006
DAVID PREGNANCY TEST (MIDSTREAM)
K053236 · LCX
Runbio Biotech Co.,Ltd
Chemistry · 242d
Cleared Jul 18, 2006
VERIFY DRY HEAT LABEL
K053479 · JOJ
Albert Browne , Ltd.
General Hospital · 216d
Cleared Jul 18, 2006
SMARTPILL GI MONITORING SYSTEM
K053547 · NYV
The Smartpill Corporation
Gastroenterology & Urology · 210d
Cleared Jul 18, 2006
POLYPLEX STIMULATING CATHETER SYSTEM
K060186 · CAZ
Te ME NA Sas
Anesthesiology · 175d
Cleared Jul 18, 2006
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
K060751 · NFB
Inovo, Inc.
Anesthesiology · 119d
Cleared Jul 18, 2006
COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
K060859 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 112d
Cleared Jul 18, 2006
EMBEDDING TOOL, MODEL TE-1000
K060897 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 106d
Cleared Jul 18, 2006
ORTHOPEDIC SOURCE PRESS-FIT HIP
K061124 · LPH
Orthopedic Source, Inc.
Orthopedic · 85d
Cleared Jul 18, 2006
PCA 36MM FEMORAL HEADS
K061168 · LPH
Howmedica Osteonics Corp.
Orthopedic · 82d
Cleared Jul 18, 2006
CD HORIZON SPINAL SYSTEM
K061304 · NQP
Medtronic Sofamor Danek
Orthopedic · 69d
Cleared Jul 18, 2006
BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK
K061307 · GEI
Aaron Medical Industries
General & Plastic Surgery · 69d
Cleared Jul 18, 2006
SANARUS VISICA TREATMENT SYSTEM
K061510 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 47d
Cleared Jul 18, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061536 · JWY
Dade Behring, Inc.
Microbiology · 46d