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"
2521–2544 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 29, 2008
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP),...
K081294 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Jul 29, 2008
REPROCESSED MASIMO PULSE OXIMETER SENSORS
K081238 · NLF
Ascent Healthcare Solutions
Anesthesiology · 89d
Cleared Jul 28, 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
K081976 · LLZ
Agfa Healthcare Corporation
Radiology · 17d
Cleared Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K081963 · MQB
Agfa Healthcare Corporation
Radiology · 15d
Cleared Jul 25, 2008
HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
K080969 · CAF
Medi Nuclear Corp., Inc.
Anesthesiology · 112d
Cleared Jul 21, 2008
AG-605 BLOOD GLUCOSE MONITORING SYSTEM
K073030 · NBW
Andon Health Co, Ltd.
Chemistry · 269d
Cleared Jul 17, 2008
ADVIA CENTAUR HAVM ASSAY
K081716 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 29d
Cleared Jul 09, 2008
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K081329 · NLH
Ascent Healthcare Solutions
Cardiovascular · 58d
Cleared Jul 07, 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683 · JIT
Siemens Healthcare Diagnostics
Chemistry · 20d
Cleared Jul 03, 2008
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS,...
K081643 · MMI
Siemens Healthcare Diagnostics
Chemistry · 21d
Cleared Jul 02, 2008
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
K081300 · JHM
Siemens Healthcare Diagnostics
Chemistry · 55d
Cleared Jul 02, 2008
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080319 · DXN
Andon Health Co, Ltd.
Cardiovascular · 147d
Cleared Jun 27, 2008
INTEL HEALTH GUIDE, MODEL: PHS6000
K080798 · DRG
Intel Corp.
Cardiovascular · 99d
Cleared Jun 26, 2008
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
K080734 · BTY
Viasys Healthcare GmbH
Anesthesiology · 104d
Cleared Jun 20, 2008
PRO TENS, MODEL WL-240 RX
K080304 · GZJ
Well-Life Healthcare Limited
Neurology · 136d
Cleared Jun 19, 2008
MICRO-TOUCH NITRAFREE
K080536 · LZA
Ansell Healthcare Products, LLC
General Hospital · 113d
Cleared Jun 11, 2008
PRECISION 500D R&F X-RAY SYSTEM
K081091 · JAA
Ge Healthcare
Radiology · 56d
Cleared May 28, 2008
UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE...
K080551 · JOW
University of Utah Hospitals and Clinics
Cardiovascular · 90d
Cleared May 28, 2008
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862,...
K080424 · NLF
Hygia Health Services, Inc.
Anesthesiology · 103d
Cleared May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF...
K081074 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared May 23, 2008
CLEANSE.FRESHEN.GO
K080631 · EFT
Oral Health Technologies, LLC
Dental · 79d
Cleared May 19, 2008
MODIFICATION TO 3M TEGADERM CHG DRESSING
K080620 · FRO
3M Company-3M Health Care
General & Plastic Surgery · 76d
Cleared May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
K071889 · DSI
Ge Healthcare
Cardiovascular · 315d