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
8761–8784 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 30, 1998
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982807 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d
Cleared Sep 30, 1998
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON...
K982822 · CAK
Baxter Healthcare Corp
General Hospital · 50d
Cleared Sep 28, 1998
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720
K981394 · DXH
Braemar Corp.
General Hospital · 164d
Cleared Sep 25, 1998
BLUNT SYRINGE CANNULA
K971924 · FMI
B.Braun Medical, Inc.
General Hospital · 490d
Cleared Sep 25, 1998
HUMAPEN AND HUMAPEN ERGO
K982842 · FMF
Eli Lilly and Co.
General Hospital · 44d
Cleared Sep 22, 1998
MODIFICATION TO SYSTEM 83 PLUS
K983017 · NVE
Custom Ultrasonics
General Hospital · 25d
Cleared Sep 16, 1998
MINI POLYURETHANE CATHETER
K982507 · LJT
Med Institute, Inc.
General Hospital · 58d
Cleared Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
K980566 · FOZ
Boston Scientific Corp
General Hospital · 213d
Cleared Sep 14, 1998
LICHEN, BACTERIAL IN LINE BREATHING FILTER
K980662 · CAH
Dhd Healthcare Corp.
General Hospital · 206d
Cleared Sep 10, 1998
CETYLCIDE-G
K974188 · MED
Kellerandheckman
General Hospital · 307d
Cleared Sep 10, 1998
SURGEON'S GLOVE
K982589 · KGO
Shiva Medicare , Ltd.
General Hospital · 48d
Cleared Sep 04, 1998
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5...
K982102 · MEB
Baxter Healthcare Corp
General Hospital · 81d
Cleared Sep 04, 1998
COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Sep 02, 1998
MEDSCI 3% GLUTARALDEHYDE
K974062 · MED
Medsci, Inc.
General Hospital · 310d
Cleared Sep 02, 1998
QUANTI-TEST SYSTEM
K982578 · SCL
Panatrex, Inc.
General Hospital · 41d
Cleared Sep 02, 1998
OMNI PRO LATEX SURGICAL GLOVE, POWDERED
K982613 · KGO
Omnigrace (Thailand) , Ltd.
General Hospital · 37d
Cleared Aug 25, 1998
BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD...
K973593 · FRN
Bridge Medical, Inc.
General Hospital · 337d
Cleared Aug 24, 1998
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
K981272 · MQX
Electro Therapeutic Devices, Inc.
General Hospital · 139d
Cleared Aug 24, 1998
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · FYC
Allegiance Healthcare Corp.
General Hospital · 48d
Cleared Aug 24, 1998
MPS FIXED FLOW RATE SET
K982587 · FPA
Medical Product Specialists
General Hospital · 31d
Cleared Aug 18, 1998
CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
K980109 · KYX
Sangstat Medical Corp.
General Hospital · 218d
Cleared Aug 18, 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K980916 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 160d
Cleared Aug 18, 1998
STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO....
K981905 · FOZ
Acu-Pak
General Hospital · 78d
Cleared Aug 17, 1998
SOLUTION ADMINISTRATION SET
K981792 · FPA
Baxter Healthcare Corp
General Hospital · 88d