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
9985–10008 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 09, 1996
DRAGER INFANT RADIANT WARMERN RH600
K953489 · FMT
Drager, Inc.
General Hospital · 199d
Cleared Feb 09, 1996
PRO-TECH
K955850 · LRJ
Central Solutions, Inc.
General Hospital · 44d
Cleared Feb 08, 1996
ABRM CATHETER
K950118 · FOZ
Cook, Inc.
General Hospital · 393d
Cleared Feb 08, 1996
BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET
K955727 · MEB
I-Flow Corp.
General Hospital · 52d
Cleared Feb 07, 1996
VLV SA.EF INFUSION PORT EXTENSION SETS
K955783 · FPA
Vlv Associates, Inc.
General Hospital · 48d
Cleared Feb 06, 1996
THE AIRCEL SYSTEM
K954593 · FNM
Marcon Group, Inc.
General Hospital · 126d
Cleared Feb 06, 1996
MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
K955896 · LHI
Critical Device Corp.
General Hospital · 39d
Cleared Jan 30, 1996
DARWIN HYPODERMIC SAFETY SYSTEM (DHSS)
K952837 · FMI
Emk Enterprises, LLC
General Hospital · 225d
Cleared Jan 30, 1996
VENIPUNCTURE KIT
K954823 · FPA
Winfield Industries
General Hospital · 102d
Cleared Jan 30, 1996
OLYMPIC SMART SCALE MODEL 50/50RA
K955357 · FRW
Olympic Medical Corp.
General Hospital · 99d
Cleared Jan 29, 1996
AMPRI
K954002 · KGO
Ampri Rubberware Industries Sdn Bhd
General Hospital · 157d
Cleared Jan 29, 1996
PEN-INJECT 2.25
K954729 · KZH
Scandinavian Health , Ltd.
General Hospital · 108d
Cleared Jan 26, 1996
MIELE G 7781 DENTAL THERMAL DISINFECTOR
K950518 · LDS
Miele Professional
General Hospital · 354d
Cleared Jan 26, 1996
STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
K953529 · LJT
Strato/Infusaid, Inc.
General Hospital · 183d
Cleared Jan 26, 1996
ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET
K953746 · FPA
Arrow Intl., Inc.
General Hospital · 169d
Cleared Jan 26, 1996
GLOBAL HEALTHCARE FACE MASK
K953754 · FXX
Global Healthcare, Inc.
General Hospital · 168d
Cleared Jan 26, 1996
ARISTA VINYL EXAMINATION GLOVES
K954153 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 143d
Cleared Jan 25, 1996
LACERATION TRAY
K955658 · FRG
Transidyne General Corp.
General Hospital · 44d
Cleared Jan 24, 1996
STERILE WATER O.9% STERILE SALINE
K954887 · FOZ
Lockett Medical Corp.
General Hospital · 100d
Cleared Jan 24, 1996
MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
K955149 · BYY
Bio-Medical Devices, Inc.
General Hospital · 72d
Cleared Jan 24, 1996
MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
K955151 · BYY
Bio-Medical Devices, Inc.
General Hospital · 72d
Cleared Jan 23, 1996
KLORMAN
K923693 · LRJ
Matrix Medica, Inc.
General Hospital · 1279d
Cleared Jan 23, 1996
I.V. ADMINISTRATION SET CONNECTING DEVICE
K940832 · FPA
Sierra Medical Devices
General Hospital · 699d
Cleared Jan 23, 1996
BODY FLUID BARRIER KIT
K952961 · FXX
Lhb Industries, Inc.
General Hospital · 211d