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"
3121–3144 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 31, 2003
SETPOINT CHEMISTRY CALIBRATOR
K030169 · JIX
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 31, 2003
AHL GENERIC GLASS IONOMER LUTING CEMENT
K023981 · EMA
Advanced Healthcare , Ltd.
Dental · 60d
Cleared Jan 28, 2003
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024081 · LYZ
Safehealth Medical Supply Corp.
General Hospital · 48d
Cleared Jan 24, 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
K030102 · JJT
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 24, 2003
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
K023826 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 67d
Cleared Jan 16, 2003
RADIONICS VARILINK 2
K023519 · IYE
Radionics, A Division of Tyco...
Radiology · 87d
Cleared Jan 16, 2003
PRE-POWDERED LATEX SURGEON'S GLOVES
K023515 · KGO
Sanrea Healthcare Private Limited
General Hospital · 87d
Cleared Jan 15, 2003
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · FCG
Allegiance Healthcare Corp.
Gastroenterology & Urology · 30d
Cleared Jan 14, 2003
HL888
K023834 · DXN
Health & Life Co., Ltd.
Cardiovascular · 57d
Cleared Jan 09, 2003
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH...
K024292 · LYY
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Dec 30, 2002
PREPARE ADMINISTRATION SET
K023769 · FPA
Appro Healthcare, Inc.
General Hospital · 48d
Cleared Dec 30, 2002
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403),...
K020020 · GZJ
Well-Life Healthcare, Inc.
Neurology · 361d
Cleared Dec 26, 2002
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
K023259 · FDF
Helix Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Dec 24, 2002
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
K021509 · JOW
Hygia Health Services, Inc.
Cardiovascular · 229d
Cleared Dec 23, 2002
LTFS230
K021775 · LNS
Healthtronics, Inc.
Gastroenterology & Urology · 208d
Cleared Dec 20, 2002
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
K024036 · IPF
Johari Digital Healthcare , Ltd.
Physical Medicine · 14d
Cleared Dec 18, 2002
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K024102 · LYY
Allegiance Healthcare Corp.
General Hospital · 6d
Cleared Dec 18, 2002
BURETTE-IN LINE (150 ML)
K023595 · FPA
Tuta Healthcare Pty Limited
General Hospital · 51d
Cleared Dec 12, 2002
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773,...
K021682 · DXN
Omron Healthcare, Inc.
Cardiovascular · 204d
Cleared Dec 12, 2002
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
K013562 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 412d
Cleared Dec 02, 2002
MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
K020837 · LYY
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 263d
Cleared Nov 22, 2002
804SIII
K021846 · GZJ
Body Clock Health Care, Ltd.
Neurology · 170d
Cleared Nov 21, 2002
BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211
K022916 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 79d
Cleared Nov 19, 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 252d