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
51145–51168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218 · FRO
Coloplast A/S
General & Plastic Surgery · 22d
Cleared Feb 17, 2010
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
K100242 · FZP
Surgical Devices, A Division of Tyco...
General & Plastic Surgery · 21d
Cleared Feb 17, 2010
G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333
K100251 · GAT
Usgi Medical
General & Plastic Surgery · 20d
Cleared Feb 17, 2010
ESTEMP NE
K100290 · EMA
Spident Co., Ltd.
Dental · 15d
Cleared Feb 16, 2010
SKELTEX ISV
K091234 · NDN
Skeltex Technologies, Inc.
Orthopedic · 295d
Cleared Feb 16, 2010
COLLAGEN SPONGE
K092805 · KGN
Innocoll Pharmaceuticals
General & Plastic Surgery · 158d
Cleared Feb 16, 2010
NON-STERILE DISPOSABLE VAGINAL SPECULUM
K092870 · HIB
Kunshan Deyi Plastic Co., Ltd.
Obstetrics & Gynecology · 151d
Cleared Feb 16, 2010
SCOPE INTRODUCER MODEL 7400
K093329 · ODC
N.M. Beale Co., Inc.
Gastroenterology & Urology · 113d
Cleared Feb 16, 2010
3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT...
K093515 · DQX
Brivant, Ltd.
Cardiovascular · 95d
Cleared Feb 16, 2010
TROPAZONE CR
K093544 · FRO
Midlothian Laboratories
General & Plastic Surgery · 91d
Cleared Feb 16, 2010
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT
K093824 · DXN
Health & Life Co., Ltd.
Cardiovascular · 64d
Cleared Feb 12, 2010
WAYPOINT STEREOTACTIC SYSTEM
K092192 · HAW
FHC, Inc.
Neurology · 206d
Cleared Feb 12, 2010
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
K092421 · HIH
Gimmi GmbH
Obstetrics & Gynecology · 189d
Cleared Feb 12, 2010
COMFORTGEL NASAL MASK
K092835 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 150d
Cleared Feb 12, 2010
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
K093004 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 137d
Cleared Feb 12, 2010
STRAUMANN RC TEMPORARY ABUTMENTS
K093027 · DZE
Straumann USA
Dental · 136d
Cleared Feb 12, 2010
ENDOSCOPE REPROCESSOR OER-PRO
K093106 · FEB
Olympus Medical Systems Corporation
General Hospital · 134d
Cleared Feb 12, 2010
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND...
K093138 · IPF
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 130d
Cleared Feb 12, 2010
FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE
K093192 · JOM
Advanced Vascular Dynamics
Cardiovascular · 126d
Cleared Feb 12, 2010
SIMPLISEAL
K093208 · KIF
Discus Dental, LLC
Dental · 122d
Cleared Feb 12, 2010
SELF ADHESIVE COMPOSITE LUTING CEMENT
K093338 · EMA
Dmg USA, Inc.
Dental · 112d
Cleared Feb 12, 2010
MINI LAP RETRACTORS
K093449 · GCJ
Mini Lap Technologies, Inc.
General & Plastic Surgery · 99d
Cleared Feb 12, 2010
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631 · CDD
Siemens Healthcare Diagnostics
Chemistry · 80d
Cleared Feb 12, 2010
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
K093696 · LZA
Central Medicare Sdn Bhd
General Hospital · 74d