FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,754 results
9121–9144 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 03, 1997
BABYTHERM 8004 BABYTHERM 8010
K971198 · FMT
Drager, Inc.
General Hospital · 186d
Cleared Oct 03, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K972169 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 116d
Cleared Oct 02, 1997
MEDCORP FLOW I.V. REGULATOR EXTENSION SET
K971004 · FPA
Medcorp Intl.
General Hospital · 197d
Cleared Oct 02, 1997
AMSINO I.V. ADMINISTRATION SET
K973107 · FPA
Amsino Intl., Inc.
General Hospital · 44d
Cleared Oct 01, 1997
PERACT 20 LIQUID STERILANT
K960513 · MED
Minntech Corp.
General Hospital · 604d
Cleared Oct 01, 1997
CORE RESISTANT HUBER INFUSION SETS
K972712 · FPA
Icu Medical, Inc.
General Hospital · 72d
Cleared Sep 29, 1997
SA-EF MULTI-LUMEN EXTENSION SET
K972957 · FPA
Vlv Associates, Inc.
General Hospital · 49d
Cleared Sep 26, 1997
SPORTROL RAPID STERILITY INDICATOR
K962649 · MTC
North American Science Assoc., Inc.
General Hospital · 445d
Cleared Sep 26, 1997
NITRILE EXAMINATION GLOVES-PRE POWDERED
K970216 · LZA
Influx Pacific Sdn. Bhd.
General Hospital · 253d
Cleared Sep 24, 1997
DUO-LITE PHOTOTHERAPY SYSTEM
K971256 · LBI
Air-Shields, Inc.
General Hospital · 173d
Cleared Sep 24, 1997
OLYMPIC BILI-BASSINET
K971601 · LBI
Olympic Medical Corp.
General Hospital · 146d
Cleared Sep 24, 1997
DISETRONIC PENFINE INJECTION PEN NEEDLE
K973339 · FMI
Disetronic Medical Systems
General Hospital · 19d
Cleared Sep 22, 1997
ULTRASOUND SYSTEMS DRAPE
K970885 · MMP
Protek Medical Products, Inc.
General Hospital · 195d
Cleared Sep 19, 1997
TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
K965154 · LRT
Albert Browne , Ltd.
General Hospital · 270d
Cleared Sep 19, 1997
KENTRON'S ISOLATION GOWN
K971917 · FYC
Kentron Health Care, Inc.
General Hospital · 119d
Cleared Sep 19, 1997
IMPERVIOUS ISOLATION GOWN
K972410 · FYC
Kentron Health Care, Inc.
General Hospital · 85d
Cleared Sep 19, 1997
CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K972785 · LYY
Ansell Perry
General Hospital · 56d
Cleared Sep 18, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K972493 · FPA
Nipro Medical Corp.
General Hospital · 77d
Cleared Sep 18, 1997
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
K972527 · FPA
Quality System Consulting
General Hospital · 73d
Cleared Sep 16, 1997
OPPORTUNITY, INC. LACERATION TRAY
K971089 · KKX
Opportunity, Inc.
General Hospital · 176d
Cleared Sep 15, 1997
FIRST PICC CATHETER
K972262 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 90d
Cleared Sep 15, 1997
FIRST PICC CATHETER WITH DUAL LUMENS
K972263 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 90d
Cleared Sep 15, 1997
FIRST MIDCATH CATHETER
K972264 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 90d
Cleared Sep 15, 1997
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
K973044 · LZG
Disetronic Medical Systems
General Hospital · 31d