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

5,280 results for "health"
2017–2040 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
K122398 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 66d
Cleared Oct 05, 2012
C1-6-D ULTRASOUND TRANSDUCER
K122921 · ITX
Ge Healthcare
Radiology · 11d
Cleared Oct 03, 2012
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599 · DDR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Oct 03, 2012
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K122114 · IYN
Ge Healthcare
Radiology · 78d
Cleared Oct 03, 2012
AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER
K122009 · IYN
Panasonic Healthcare Co., Ltd.
Radiology · 86d
Cleared Oct 02, 2012
ESON NASAL MASK
K121597 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 124d
Cleared Sep 26, 2012
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500...
K122507 · FRG
Cardinal Health200, LLC
General Hospital · 40d
Cleared Sep 26, 2012
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
K113483 · JAK
Philips Healthcare (Cleveland)
Radiology · 308d
Cleared Sep 21, 2012
VOLUSON E6/E8/E8EXPERT/E10
K122327 · IYN
Ge Healthcare
Radiology · 51d
Cleared Sep 20, 2012
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY...
K121926 · LZC
Northstar Healthcare Holdings
General Hospital · 80d
Cleared Sep 19, 2012
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
K121224 · LFR
Taidoc Technology Corporation
Chemistry · 152d
Cleared Sep 14, 2012
LULLABY TM WARMER
K121625 · FMT
Wipro GE Healthcare Private, Ltd.
General Hospital · 105d
Cleared Sep 13, 2012
DX-D FULL LEG FULL SPINE
K122119 · KPR
Afga Healthcare N.V.
Radiology · 58d
Cleared Sep 11, 2012
C2-9-D ULTRASOUND TRANSDUCER
K122515 · ITX
Ge Healthcare
Radiology · 25d
Cleared Sep 11, 2012
VOLUSON P6, VOLUSON P8
K122387 · IYN
Ge Healthcare
Radiology · 36d
Cleared Sep 10, 2012
ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
K121947 · LZA
Northstar Healthcare Holdings
General Hospital · 69d
Cleared Sep 10, 2012
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K121372 · DXN
Andon Health Co, Ltd.
Cardiovascular · 126d
Cleared Sep 07, 2012
MINI PATCH
K121353 · NUH
Well-Life Healthcare Limited
Neurology · 126d
Cleared Sep 04, 2012
ARC ENDOCUFF
K122565 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 13d
Cleared Aug 29, 2012
HEM-7200-Z (BP742)
K121932 · DXN
Omron Healthcare, Inc.
Cardiovascular · 58d
Cleared Aug 28, 2012
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION...
K122323 · CJO
Siemens Healthcare Diagnostics
Chemistry · 27d
Cleared Aug 28, 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY...
K120246 · MUE
Carestream Health, Inc.
Radiology · 214d
Cleared Aug 16, 2012
OEC 9900 ELITE
K122234 · OWB
Ge Healthcare Surgery GE Oec Medical...
Radiology · 21d
Cleared Aug 16, 2012
DX-D IMAGING PACKAGE
K121095 · MQB
Agfa Healthcare N.V.
Radiology · 127d