FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13537–13560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 17, 2022
Imperative Care Radial 088 Access System
K220807 · QJP
Imperative Care, Inc.
Neurology · 60d
Cleared May 17, 2022
MULTIX Impact E
K220919 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared May 17, 2022
syngo.CT CaScoring
K221219 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared May 17, 2022
BriefCase
K221240 · QAS
Aidoc Medical , Ltd.
Radiology · 18d
Cleared May 16, 2022
Clicky Cross
K210516 · FMG
Yomura Technologies, Inc.
General Hospital · 447d
Cleared May 16, 2022
SONON Ultrasound Imaging System, Model: SONON300C
K211665 · IYN
Healcerion Co., Ltd.
Radiology · 349d
Cleared May 16, 2022
Caas Qardia
K212376 · LLZ
Pie Medical Imaging BV
Radiology · 290d
Cleared May 16, 2022
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
K213583 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 185d
Cleared May 16, 2022
AAMI3 Isolation Gown
K213832 · FYC
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 158d
Cleared May 16, 2022
STERRAD NX with ALLClear Technology
K220404 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 91d
Cleared May 16, 2022
IPL HAIR REMOVAL HANDSET, Model: IPL-666
K220669 · OHT
Shenzhen Junbobeauty Technology Co.,...
General & Plastic Surgery · 70d
Cleared May 14, 2022
Disposable Medical Nitrile Examination Gloves -Tested for Use with...
K220491 · LZC
Hainan Asther Medical Equipment Co.,...
General Hospital · 81d
Cleared May 14, 2022
Introcan Safety IV Catheter
K220626 · FOZ
B.Braun Medical, Inc.
General Hospital · 71d