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

5,281 results for "health"
3313–3336 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · DBA
Baxter Healthcare Corp
Immunology · 105d
Cleared Mar 19, 2001
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
K002665 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 206d
Cleared Mar 12, 2001
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K010548 · HAW
Radionics, A Division of Tyco...
Neurology · 14d
Cleared Feb 28, 2001
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
K010077 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Feb 23, 2001
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
K003749 · FYC
Banta Healthcare
General Hospital · 81d
Cleared Feb 21, 2001
MEDRELIEF
K003507 · GZJ
Healthonics, Inc.
Neurology · 100d
Cleared Feb 15, 2001
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · LZC
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 208d
Cleared Feb 06, 2001
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT...
K004048 · LYY
Tillotson Healthcare Corp.
General Hospital · 39d
Cleared Feb 05, 2001
LIVESURE THC SCREEN TEST
K010001 · LDJ
Pan Probe Biotech, Inc.
Toxicology · 34d
Cleared Jan 26, 2001
FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING...
K002719 · LYY
Tillotson Healthcare Corp.
General Hospital · 148d
Cleared Jan 16, 2001
ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT...
K003771 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 41d
Cleared Dec 27, 2000
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
K003815 · INI
Merits Health Products., Inc.
Physical Medicine · 16d
Cleared Dec 22, 2000
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
K003769 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 16d
Cleared Dec 20, 2000
CHEMO-AIDE DISPENSING PIN
K003730 · LHI
Baxter Healthcare Corp
General Hospital · 16d
Cleared Dec 12, 2000
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K003616 · FRN
Baxter Healthcare Corp
General Hospital · 20d
Cleared Dec 08, 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 170d
Cleared Dec 05, 2000
ACAPELLA
K002768 · BWF
Dhd Healthcare Corp.
Anesthesiology · 90d
Cleared Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100...
K003245 · FOZ
Baxter Healthcare Corp
General Hospital · 48d
Cleared Nov 22, 2000
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · KNW
Allegiance Healthcare Corp.
Gastroenterology & Urology · 23d
Cleared Nov 21, 2000
CLINIFLO INCENTIVE SPIROMETER
K003146 · BWF
Dhd Healthcare Corp.
Anesthesiology · 42d
Cleared Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
K001685 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 167d
Cleared Nov 09, 2000
FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K002720 · LYY
Tillotson Healthcare Corp.
General Hospital · 70d
Cleared Nov 07, 2000
DUPLOGRIP
K003193 · FMF
Baxter Healthcare Corp
General Hospital · 26d