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

5,198 results for "health"
673–696 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 28, 2022
Magnum
K220670 · FXX
Magnum Health and Safety Pvt, Ltd.
General Hospital · 113d
Cleared Jun 23, 2022
Ultrasound System SONIMAGE MX1
K220993 · IYN
Konica Minolta, Inc.
Radiology · 80d
Cleared Jun 23, 2022
CoLumbo
K220497 · QIH
Smart Soft Healthcare AD
Radiology · 121d
Cleared Jun 22, 2022
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting...
K220413 · QPP
Canary Medical USA, LLC
Orthopedic · 128d
Cleared Jun 21, 2022
Syngo Carbon Space VA20A
K213665 · LLZ
Siemens Healthcare GmbH
Radiology · 211d
Cleared Jun 10, 2022
Surgical Isolation Cover Gown
K220528 · FYC
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 106d
Cleared Jun 09, 2022
MyCRO Band
K213587 · MVA
Otto Bock Healthcare LP
Neurology · 209d
Cleared Jun 08, 2022
AIR Recon DL
K213717 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 196d
Cleared Jun 06, 2022
Diacare 7000
K211207 · PBX
Globus Sport and Health Technologies,...
General & Plastic Surgery · 410d
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG
Fujifilm Corporation
Radiology · 157d
Cleared Jun 01, 2022
FROG Forceps Valve (VAL1-F1-100)
K221264 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 30d
Cleared May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · OWQ
Innovative Health, LLC
Cardiovascular · 447d
Cleared May 23, 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
K220155 · LZA
Motex Healthcare (Anhui) Co., Ltd.
General Hospital · 124d
Cleared May 23, 2022
SCENARIA View
K213829 · JAK
Fujifilm Healthcare Corporation
Radiology · 166d
Cleared May 19, 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220370 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 99d
Cleared May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174 · PIF
Cardinalhealth
Gastroenterology & Urology · 233d
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 12, 2022
Saige-Dx
K220105 · QDQ
DeepHealth, Inc.
Radiology · 120d
Cleared May 11, 2022
Durex Condom with Benzocaine
K211152 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 387d
Cleared May 06, 2022
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar...
K212289 · QCI
Neuronetics, Inc.
Neurology · 289d
Cleared May 03, 2022
Orchid Safety Release Valve(TM)
K212064 · QOI
Linear Health Sciences, LLC
General Hospital · 305d
Cleared Apr 29, 2022
Oxehealth Vital Signs
K220899 · QME
Oxehealth Limited
Cardiovascular · 32d
Cleared Apr 29, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K220417 · FRN
Baxter Healthcare Corporation
General Hospital · 74d
Cleared Apr 29, 2022
ARIETTA 50
K220295 · IYN
Fujifilm Healthcare Corporation
Radiology · 86d