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"
3169–3192 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 16, 2001
TWINTRODE ELC 134 ELECTRODE
K012785 · LNS
Healthtronics Surgical Services, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 13, 2001
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
K013604 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL...
K013603 · KGO
Ansell Healthcare Products, Inc.
General Hospital · 13d
Cleared Nov 13, 2001
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
K012815 · LYY
Kimberly-Clark Corp.
General Hospital · 83d
Cleared Nov 08, 2001
LIFTLOC SAFETY INFUSION SET
K013394 · FPA
Specialized Health Products, Inc.
General Hospital · 24d
Cleared Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
K011652 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 162d
Cleared Oct 25, 2001
MONOJECT SAFETY NEEDLE
K012736 · FMI
Tyco Healthcare
General Hospital · 70d
Cleared Oct 23, 2001
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · DXN
Health & Life Co., Ltd.
Cardiovascular · 43d
Cleared Oct 19, 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · LZA
Tillotson Healthcare Corp.
General Hospital · 42d
Cleared Oct 12, 2001
CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE...
K013286 · LYY
Tillotson Healthcare Corp.
General Hospital · 10d
Cleared Oct 05, 2001
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
K010706 · MNW
Measurement Specialties, Inc.
Gastroenterology & Urology · 210d
Cleared Oct 04, 2001
END EXPIRATORY FILTER, MODEL RT020
K002839 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 387d
Cleared Sep 24, 2001
BREATHABLE IMPERVIOUS GOWNS
K012984 · FYA
Allegiance Healthcare Corp.
General Hospital · 18d
Cleared Sep 24, 2001
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM
K012149 · LYY
Allegiance Healthcare Corp.
General Hospital · 76d
Cleared Sep 21, 2001
STS RANGE , MODELS STS20,STS30,STS40
K012008 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 86d
Cleared Sep 21, 2001
PRE-POWDERED NITRILE EXAMINATION GLOVES
K010232 · LZA
P.T. Healthcare Glovindo
General Hospital · 240d
Cleared Sep 19, 2001
RHS HELMET
K012007 · MVA
Restorative Health Svs, Inc.
Neurology · 84d
Cleared Sep 18, 2001
MP3CF ELECTRIC WHEELCHAIR
K012802 · ITI
Merits Health Products., Inc.
Physical Medicine · 28d
Cleared Sep 17, 2001
CLINCARE LATEX SURGEON'S GLOVE
K012067 · KGO
Ttk Healthcare , Ltd.
General Hospital · 77d
Cleared Sep 10, 2001
AQUANET, MODEL EC 2000
K000031 · KPL
Prime Pacific Health Innovations...
Gastroenterology & Urology · 614d
Cleared Sep 06, 2001
VERASTEP
K012539 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 30d
Cleared Sep 05, 2001
MHS 5000
K011981 · LHQ
Micro Health Systems, Inc.
Radiology · 72d
Cleared Aug 30, 2001
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH...
K012489 · DYB
Appriva Medical, Inc.
Cardiovascular · 27d
Cleared Aug 28, 2001
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K011844 · CAW
Merits Health Products., Inc.
Anesthesiology · 77d