FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
13249–13272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2022
X-Twist PEEK Suture Anchor
K221135 · MBI
Parcus Medical, LLC
Orthopedic · 30d
Cleared May 19, 2022
Univers Revers Humeral Cup Implant
K221232 · HSD
Arthrex, Inc.
Orthopedic · 20d
Cleared May 18, 2022
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy...
K212408 · LZA
Pt. Maja Agung Latexindo
General Hospital · 288d
Cleared May 18, 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood...
K212416 · DXQ
Wenzhou Xikang Medical Instruments...
Cardiovascular · 288d
Cleared May 18, 2022
MolecuLight I:X
K213840 · QJF
Moleculight, Inc.
General & Plastic Surgery · 160d
Cleared May 18, 2022
GSS610N21 Series Steam Sterilizer
K214120 · FLE
Maquet GmbH
General Hospital · 139d
Cleared May 18, 2022
Nitrile Powder Free Examination Gloves
K220211 · LZA
Hebei Kangxida Medical Technology...
General Hospital · 112d
Cleared May 18, 2022
Siren SGT
K220218 · KNT
Tools For Surgery, LLC
Gastroenterology & Urology · 112d
Cleared May 18, 2022
Medline Orbis LVL 3 Surgical Gown
K220333 · FYA
Medline Industries, LP
General Hospital · 103d
Cleared May 18, 2022
Osteotomy Truss System (OTS)
K220463 · HRS
4Web Medical, Inc.
Orthopedic · 90d
Cleared May 18, 2022
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices...
K220467 · GEX
Lumenis Be, Ltd.
General & Plastic Surgery · 90d
Cleared May 18, 2022
BENCOX Mirabo Cup System
K220468 · LPH
Corentec Co., Ltd.
Orthopedic · 90d
Cleared May 18, 2022
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel...
K220917 · FMK
Gri-Alleset, Inc.
General & Plastic Surgery · 49d
Cleared May 17, 2022
Medline Integrated Arterial Catheter
K210548 · DQX
Centurion Medical Products
Cardiovascular · 446d
Cleared May 17, 2022
Neoss Individual Prosthetics
K211396 · NHA
Neoss, Ltd.
Dental · 377d
Cleared May 17, 2022
Cervical Spine Truss System Plating Solution (CSTS-PS)
K212527 · KWQ
4Web Medical, Inc.
Orthopedic · 279d
Cleared May 17, 2022
Biocore9 Acetabular Cup System
K212761 · LPH
Biocore9, LLC
Orthopedic · 259d
Cleared May 17, 2022
SternaLock Sternal Closure System
K212782 · HRS
Biomet Microfixation
Orthopedic · 258d
Cleared May 17, 2022
Monaco RTP System
K213787 · MUJ
Elekta Solutions AB
Radiology · 162d
Cleared May 17, 2022
Skin Care Beauty Mask (Model: MJ-06)
K220168 · OHS
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 117d
Cleared May 17, 2022
Procedure mask/Surgical mask/Face mask
K220194 · FXX
Winner Medical Co., Ltd.
General Hospital · 113d
Cleared May 17, 2022
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
K220372 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 97d
Cleared May 17, 2022
Rapid PE Triage and Notification (PETN)
K220499 · QAS
Ischemaview, Inc.
Radiology · 84d
Cleared May 17, 2022
CATALYS Precision Laser system
K220516 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 83d