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
8257–8280 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 05, 1999
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
K993325 · LZA
Innovative Gloves Co;, Ltd.
General Hospital · 32d
Cleared Nov 02, 1999
DECAP
K993147 · FPA
The Kipp Group
General Hospital · 42d
Cleared Nov 01, 1999
ABSOGEL CHEMOTHERAPHY GLOVES
K990677 · LZC
Ampri Rubberware Industries Sdn Bhd
General Hospital · 244d
Cleared Nov 01, 1999
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
K993387 · FRN
Baxter Healthcare Corp
General Hospital · 24d
Cleared Oct 29, 1999
TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
K992841 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 66d
Cleared Oct 29, 1999
SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
K992953 · KGO
Ansell Perry
General Hospital · 58d
Cleared Oct 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
K993093 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 43d
Cleared Oct 29, 1999
POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING...
K993287 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 28d
Cleared Oct 27, 1999
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
K983613 · LYZ
Shanghai Jiatai Plastic Products Co.,...
General Hospital · 378d
Cleared Oct 27, 1999
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
K992156 · LYZ
Ansell Perry
General Hospital · 124d
Cleared Oct 27, 1999
IV ADMINISTRATION SET
K992266 · FPA
New Alliance of Independent Medical...
General Hospital · 113d
Cleared Oct 27, 1999
ALPHA INFUSION PUMP
K992551 · MEB
Advanced Infusion, Inc.
General Hospital · 89d
Cleared Oct 27, 1999
TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201,...
K992601 · FLL
Oriental System Technology, Inc.
General Hospital · 85d
Cleared Oct 27, 1999
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER...
K992830 · LZA
Safeskin Corp.
General Hospital · 65d
Cleared Oct 27, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH...
K993097 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 41d
Cleared Oct 27, 1999
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE...
K993231 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 30d
Cleared Oct 27, 1999
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH...
K993240 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 30d
Cleared Oct 27, 1999
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
K993258 · LZA
Supermax Sdn Bhd
General Hospital · 28d
Cleared Oct 25, 1999
INTRAOP CATHETER
K991543 · MEB
I-Flow Corp.
General Hospital · 175d
Cleared Oct 21, 1999
CATHETER INNOVATIONS IMPLANTABLE PORT
K991897 · LJT
Catheter Innovations, Inc.
General Hospital · 139d
Cleared Oct 21, 1999
SURGEON POWDER-FREE GLOVES, LATEX, STERILE
K992679 · KGO
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 72d
Cleared Oct 20, 1999
BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
K992468 · FLL
Braun GmbH
General Hospital · 89d
Cleared Oct 20, 1999
AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING...
K993080 · LYY
Medtexx Partners, Inc.
General Hospital · 36d
Cleared Oct 19, 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · LJT
Sims Deltec, Inc.
General Hospital · 53d