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"
2473–2496 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 26, 2008
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
K083115 · DRG
Intel Corp.
Cardiovascular · 36d
Cleared Nov 26, 2008
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
K082541 · CAF
Medi Nuclear Corp., Inc.
Anesthesiology · 85d
Cleared Nov 19, 2008
THERAGEM PROFESSIONAL T1002
K081505 · ILY
Medica Health, Ltd.
Physical Medicine · 174d
Cleared Nov 14, 2008
CENTRICITY PACS WEB DIAGNOSTIC
K083018 · LLZ
Ge Healthcare Dynamic Imaging Solutions
Radiology · 36d
Cleared Nov 14, 2008
SPECTRAL OCT/SLO
K080460 · OBO
Opko Health, Inc.
Ophthalmic · 268d
Cleared Nov 10, 2008
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES...
K082457 · LZA
Ansell Healthcare Products, Inc.
General Hospital · 76d
Cleared Oct 30, 2008
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR,...
K081857 · NRP
Siemens Healthcare Diagnostics, Inc.
Toxicology · 121d
Cleared Oct 28, 2008
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
K082314 · IOR
Otto Bock Healthcare LP
Physical Medicine · 76d
Cleared Oct 27, 2008
MPOWRX SNORING SOLUTION
K081965 · LRK
Mpowrx Health and Wellness Products,...
Dental · 109d
Cleared Oct 24, 2008
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
K081732 · DAP
Siemens Healthcare Diagnostics
Hematology · 127d
Cleared Oct 22, 2008
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
K082812 · MWI
Omron Healthcare, Inc.
Cardiovascular · 28d
Cleared Oct 17, 2008
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
K081438 · DXZ
Lifenet Health
Cardiovascular · 148d
Cleared Oct 10, 2008
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
K082680 · JIT
Siemens Healthcare Diagnostics
Chemistry · 25d
Cleared Oct 10, 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · MQV
Baxter Healthcare Corp
Orthopedic · 114d
Cleared Oct 10, 2008
HEM-9000AI
K081654 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared Oct 09, 2008
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
K081670 · CBK
Cardinal Health 207, Inc.
Anesthesiology · 118d
Cleared Oct 08, 2008
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
K082486 · NBW
Bayer Healthcare, LLC
Chemistry · 41d
Cleared Oct 07, 2008
JUMAO MANUAL WHEELCHAIR
K082784 · IOR
Danyang Jumao Healthcare Equipment...
Physical Medicine · 14d
Cleared Oct 06, 2008
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
K082217 · LGZ
Arizant Healthcare, Inc.
General Hospital · 61d
Cleared Oct 01, 2008
SMARTSIGNS MINPULSE
K081572 · DQA
Huntleigh Healthcare , Ltd.
Anesthesiology · 119d
Cleared Sep 22, 2008
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT...
K082645 · NBC
Siemens Healthcare Diagnostics
Chemistry · 11d
Cleared Sep 17, 2008
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
K081738 · CAF
Health & Life Co., Ltd.
Anesthesiology · 90d
Cleared Sep 16, 2008
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K082023 · NLH
Ascent Healthcare Solutions
Cardiovascular · 62d
Cleared Sep 12, 2008
SLEEPSTYLE 200 AUTO SERIES HC254
K081029 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 154d