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"
889–912 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 26, 2021
Spacelabs Lifescreen PRO Analyzer
K201921 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 259d
Cleared Mar 26, 2021
MyCRO Band
K201426 · MVA
Otto Bock Healthcare LP
Neurology · 301d
Not Cleared Mar 26, 2021
Oxehealth Vital Signs
DEN200019 · QME
Oxehealth Limited
Cardiovascular · 364d
Cleared Mar 25, 2021
Surgical Masks, Model SNN200640 & MN112
K203776 · FXX
Sq Medical Supplies, Inc.
General Hospital · 87d
Cleared Mar 23, 2021
ICU Health Surgical Mask
K203064 · FXX
Plastikon Industries
General Hospital · 165d
Cleared Mar 19, 2021
Patient Examination Gloves
K203593 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 100d
Cleared Mar 16, 2021
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
K201723 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 266d
Cleared Mar 11, 2021
Monarch Bronchoscope
K203614 · QNW
Auris Health, Inc., A Johnson and...
Ear, Nose, Throat · 91d
Cleared Mar 10, 2021
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
K201809 · KDI
Baxter Healthcare Corportation
Gastroenterology & Urology · 252d
Cleared Mar 08, 2021
iHealth Wireless No-Touch Forehead Thermometer
K202753 · FLL
Andon Health Co, Ltd.
General Hospital · 168d
Cleared Mar 05, 2021
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K203261 · DRF
Innovative Health, LLC
Cardiovascular · 120d
Cleared Mar 05, 2021
Andorate Universal Endoscope Tip Guard
K202838 · OCU
Ga Health Company Limited
Gastroenterology & Urology · 161d
Not Cleared Mar 05, 2021
ClearUP Sinus Relief
DEN200006 · QNU
Tivic Health Systems, Inc.
Ear, Nose, Throat · 392d
Cleared Feb 25, 2021
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE,...
K201142 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 302d
Cleared Feb 19, 2021
Inbrace Orthodontic System
K203442 · PNN
Swift Health Systems, Inc.
Dental · 88d
Cleared Feb 19, 2021
Disposable Intraoperative Probe (DIOP8)
K201425 · ITX
Huntleigh Healthcare Limited
Radiology · 266d
Cleared Feb 12, 2021
Panda iRes Warmer, Giraffe Warmer
K201628 · FMT
Ge Healthcare
General Hospital · 241d
Cleared Feb 06, 2021
MouthLab Vital Signs Monitoring System
K201635 · MWI
Multisensor Diagnostics (Dba Aidar...
Cardiovascular · 235d
Cleared Feb 05, 2021
Cios Spin
K210054 · OWB
Siemens Medical Systems USA, Inc.
Radiology · 28d
Cleared Feb 01, 2021
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K203483 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 66d
Cleared Jan 29, 2021
Sunset Heated CPAP Tube
K201418 · BZE
Sunset Healthcare Solutions, Inc.
Anesthesiology · 245d
Cleared Jan 26, 2021
IBM iConnect Access
K203104 · LLZ
Merge Healthcare Incorporated
Radiology · 104d
Cleared Jan 21, 2021
Overlapped Compression Therapy
K202839 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 118d
Cleared Jan 15, 2021
IMMULITE/IMMULITE® 1000 Cortisol
K203270 · CGR
Siemens Healthcare Diagnostics...
Chemistry · 71d