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"
3241–3264 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Oct 30, 2000
CRANIOCAP
K000861 · MVA
Gillette Children'S Specialty Healthcare
Neurology · 227d
Cleared Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
K994390 · MSF
Gambro Healthcare
Gastroenterology & Urology · 303d
Cleared Oct 23, 2000
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K000838 · LYY
P.T. Healthcare Glovindo
General Hospital · 223d
Cleared Oct 19, 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · FPA
Baxter Healthcare Corp
General Hospital · 3d
Cleared Oct 13, 2000
HL168B
K002882 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Sep 25, 2000
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414 · LBI
Fisher &Paykel Healthcare , Ltd.
General Hospital · 49d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664 · DXG
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Sep 19, 2000
BABY DOPPLEX 4002-TWINS, MODEL BD4002
K001882 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 18, 2000
HL168T
K002750 · DXN
Health & Life Co., Ltd.
Cardiovascular · 13d
Cleared Sep 18, 2000
6060 MULTI-THERAPY PUMP, MODEL 2M9832
K002679 · FRN
Baxter Healthcare Corp
General Hospital · 21d