FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
14569–14592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2022
Dukal Corporation Level 1 Pediatric Face Mask
K210321 · OXZ
Dukal Corporation
General Hospital · 418d
Cleared Mar 29, 2022
Focus HD 43 Detector
K213529 · MQB
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 29, 2022
Focus HD 35 Detector
K213646 · MQB
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 29, 2022
GAL-1A Plus Blood Glucose Monitoring System
K213887 · NBW
Apex BioTechnology Corp.
Chemistry · 106d
Cleared Mar 29, 2022
Guidewire Locking Device
K220247 · ODC
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d
Cleared Mar 29, 2022
REAL INTELLIGENCE CORI
K220255 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 57d
Cleared Mar 28, 2022
SancDam Latex Oral Dam
K212037 · MSC
Sanctuary Health Sdn. Bhd.
Obstetrics & Gynecology · 271d
Cleared Mar 28, 2022
Syngo.CT Dual Energy
K212889 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Mar 28, 2022
CERABIEN MiLai
K213147 · EIH
Kuraray Noritake Dental, Inc.
Dental · 182d
Cleared Mar 28, 2022
OSSIOfiber Suture Anchor
K213415 · MAI
OSSIO , Ltd.
Orthopedic · 160d
Cleared Mar 28, 2022
Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy...
K213662 · LZA
Taishan Weibang Medical Equipment...
General Hospital · 126d
Cleared Mar 28, 2022
T3 Pro Implants
K213672 · DZE
Biomet 3i, LLC
Dental · 126d
Cleared Mar 28, 2022
Hand-held IPL device(JOVS Graphene Hair Removal Device)
K214113 · OHT
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Mar 27, 2022
GGM Breathing Circuit Bacterial Filter
K210352 · CAH
Great Group Medical Co, Ltd.
General Hospital · 412d
Cleared Mar 26, 2022
Clover Glove
K213729 · LZA
Clover Glove Company Limited
General Hospital · 120d
Cleared Mar 26, 2022
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with...
K220215 · LZA
Ksg Medicare Sdn. Bhd.
General Hospital · 59d
Cleared Mar 26, 2022
Powder Free Nitrile Examination Gloves, Orange
K220229 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 58d
Cleared Mar 25, 2022
Infusion Sets for Single Use
K202437 · FPA
Jiangsu Suyun Medical Materials Co.,...
General Hospital · 577d
Cleared Mar 25, 2022
Pluski Safe 1 Safety IV Catheter
K210037 · FOZ
Mediplus (India) Limited
General Hospital · 443d
Cleared Mar 25, 2022
Biobeat Platform, BB-613WP Patch
K212153 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 259d
Cleared Mar 25, 2022
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210...
K212231 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 252d
Cleared Mar 25, 2022
Luna G3 BPAP System
K212263 · BZD
3B Medical, Inc.
Anesthesiology · 248d
Cleared Mar 25, 2022
Nebulizer
K212395 · CAF
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 235d
Cleared Mar 25, 2022
Toro-L Interbody Fusion System
K213355 · MAX
Integrity Implants, Inc.
Orthopedic · 164d