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
8905–8928 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 17, 1998
IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT
K961486 · MRZ
Ivac Medical Systems
General Hospital · 732d
Cleared Apr 17, 1998
IV DECANTER-FLEXIBLE
K980587 · LHI
Inrad
General Hospital · 59d
Cleared Apr 14, 1998
AR SAFE NITRILE EXAMINATION GLOVES
K980589 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 56d
Cleared Apr 14, 1998
LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
K980605 · LYY
Pt. Sarana Indoprotex
General Hospital · 56d
Cleared Apr 13, 1998
SHARPS PLUS 5 GALLON SHARPS CONTAINER
K980179 · FMI
Rotonics Mfg., Inc.
General Hospital · 83d
Cleared Apr 09, 1998
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
K980471 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 62d
Cleared Apr 09, 1998
KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
K980472 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 62d
Cleared Apr 09, 1998
VACUETTE HOLDEX
K980768 · FMI
Greiner Meditech, Inc.
General Hospital · 41d
Cleared Apr 08, 1998
COLOURED POWDWR-FREE SURGICAL GLOVES
K980412 · KGO
Kenwell International , Ltd.
General Hospital · 64d
Cleared Apr 06, 1998
IV STANDS
K980336 · FOX
Clinton Industries, Inc.
General Hospital · 68d
Cleared Apr 06, 1998
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
K980470 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 59d
Cleared Apr 03, 1998
KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
K980469 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 56d
Cleared Apr 03, 1998
STERILE POWDER-FREE LATEX EXAMINATION GLOVES
K980803 · LYY
Kenwell International , Ltd.
General Hospital · 32d
Cleared Apr 03, 1998
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES
K980939 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 22d
Cleared Apr 03, 1998
SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES
K980940 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 22d
Cleared Apr 03, 1998
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED)
K980941 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 22d
Cleared Apr 02, 1998
LATEX EXAMINATION GLOVE
K974660 · LYY
Ideal Quality Sdn., Bhd.
General Hospital · 108d
Cleared Apr 02, 1998
POWDER-FREE LATEX EXAMINATION GLOVE
K974662 · LYY
Ideal Quality Sdn., Bhd.
General Hospital · 108d
Cleared Apr 02, 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181 · FMF
Terumo Medical Corp.
General Hospital · 72d
Cleared Apr 02, 1998
POWDERED LATEX EXAMINATION GLOVES
K980611 · LYY
Servicom Services Sdn Bhd
General Hospital · 99d
Cleared Apr 02, 1998
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)
K980729 · LZA
Pt. Eka Wira Asia
General Hospital · 36d
Cleared Apr 02, 1998
B-D E ML PEN
K980755 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 36d
Cleared Apr 02, 1998
TERUMO ALLERGY SYRINGE
K980796 · FMF
Terumo Corp.
General Hospital · 31d
Cleared Apr 02, 1998
NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE)
K980807 · LZA
Pt. Eka Wira Asia
General Hospital · 36d