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
8545–8568 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 09, 1999
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990543 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 06, 1999
SHARPS COLLECTION CONTAINER - SAF-T-SHELL
K982029 · FMI
American Medical Mfg., Inc.
General Hospital · 301d
Cleared Apr 06, 1999
MEDEX 3000 SERIES SYRINGE INFUSION PUMP
K982640 · FRN
Medex, Inc.
General Hospital · 251d
Cleared Apr 05, 1999
GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
K990567 · FRG
Global Healthcare, Inc.
General Hospital · 41d
Cleared Apr 04, 1999
S.P.A.R STERILE AMBULATORY RESERVOIR
K990091 · MRZ
Faulding Pharmaceutical Co.
General Hospital · 83d
Cleared Apr 02, 1999
SECOND WIND AIR PURIFIER
K980745 · FRA
Monagan Ent., Inc.
General Hospital · 400d
Cleared Apr 02, 1999
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT...
K982505 · LYY
Tillotson Healthcare Corp.
General Hospital · 256d
Cleared Apr 02, 1999
STERILE BACK SURGICAL GOWN WITH HAND TOWEL
K984422 · FYA
Medical Sterilization, Inc.
General Hospital · 113d
Cleared Apr 02, 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K990495 · LZA
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
PREPOWDERED NITRILE EXAMINATION GLOVES
K990499 · LZA
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
K990501 · LYY
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Apr 02, 1999
PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100...
K990502 · LYY
Flexitech Sdn. Bhd.
General Hospital · 44d
Cleared Mar 30, 1999
SPOROX II STERILIZING & DISINFECTING SOLUTION
K990703 · MED
Reckitt Benckiser, Inc.
General Hospital · 26d
Cleared Mar 29, 1999
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K984039 · LYY
Cranberry (M) Sdn. Bhd.
General Hospital · 137d
Cleared Mar 29, 1999
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100...
K990210 · LYY
Mexpo Intl., Inc.
General Hospital · 67d
Cleared Mar 29, 1999
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
K990267 · LZA
Shanghai Palomar Mountain Industries,...
General Hospital · 60d
Cleared Mar 29, 1999
POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
K990299 · LZA
Shanghai Palomar Mountain Industries,...
General Hospital · 56d
Cleared Mar 29, 1999
TUTOPLUS IV ADMINISTRATION SET
K990388 · FPA
Myco Medical Supplies, Inc.
General Hospital · 49d
Cleared Mar 29, 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
K990415 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 47d
Cleared Mar 29, 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990420 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 47d
Cleared Mar 25, 1999
PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT
K990208 · MEG
Science Incorporated
General Hospital · 63d
Cleared Mar 25, 1999
PEREGRINE WET SET, MODEL PD400.00
K990518 · FRN
Peregrine Surgical , Ltd.
General Hospital · 35d
Cleared Mar 23, 1999
DR180-R/OXY
K983576 · FLL
North East Monitoring, Inc.
General Hospital · 161d
Cleared Mar 23, 1999
CHEMO MINI SPIKE PLUS
K983794 · LHI
B. Braun of America, Inc.
General Hospital · 147d