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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
5497–5520 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 04, 2007
POWRSYRINGE ASPIRATOR
K072299 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 48d
Cleared Oct 04, 2007
CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
K071740 · LZA
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 99d
Cleared Oct 04, 2007
PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
K071421 · FPA
Promepla
General Hospital · 135d
Cleared Oct 04, 2007
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
K062297 · MLR
STERIS Corporation
General Hospital · 423d
Cleared Oct 03, 2007
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA...
K072512 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 27d
Cleared Sep 26, 2007
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K071998 · FMI
Arrow Intl., Inc.
General Hospital · 65d
Cleared Sep 26, 2007
DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
K070339 · FLL
Cincinnati Sub-Zero Products, Inc.
General Hospital · 233d
Cleared Sep 25, 2007
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
K072542 · FPA
Medegen Medical Manufacturing System
General Hospital · 15d
Cleared Sep 24, 2007
TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K071741 · LHI
Migada Plant
General Hospital · 89d
Cleared Sep 24, 2007
GENERAL SURGERY DRAPES
K070432 · KKX
Welmed, Inc.
General Hospital · 223d
Cleared Sep 21, 2007
POWRSYRINGE MONITOR
K072345 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 31d
Cleared Sep 21, 2007
POWRSYRINGE INJECTOR
K072318 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 32d
Cleared Sep 21, 2007
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
K070291 · FMZ
Medix I.C.S.A.
General Hospital · 234d
Cleared Sep 14, 2007
GREINER VACUETTE QUICKSHIELD COMPLETE
K072320 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 25d
Cleared Sep 14, 2007
AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
K071567 · FMI
Autosafe-Refelx, Inc.
General Hospital · 99d
Cleared Sep 14, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH...
K071170 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 140d
Cleared Sep 14, 2007
TRANS-CATHETER EXTRACTOR
K063048 · ODY
Tran Pa-C, Inc.
General Hospital · 345d
Cleared Sep 11, 2007
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
K071700 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 82d
Cleared Sep 11, 2007
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
K071465 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 105d
Cleared Sep 11, 2007
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590 · FLL
Microlife Intellectual Property GmbH
General Hospital · 194d
Cleared Sep 11, 2007
FLEXWARMER, MODELS KZ-1 AND KZ-2
K062644 · LGZ
Merlyn Associates, Inc.
General Hospital · 370d
Cleared Sep 10, 2007
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
K071565 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 95d
Cleared Sep 10, 2007
BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT...
K071414 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 112d
Cleared Sep 06, 2007
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE...
K071910 · LZA
Hartalega Sdn Bhd
General Hospital · 57d