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
6361–6384 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 22, 2004
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER
K042491 · LJS
Becton, Dickinson & CO
General Hospital · 69d
Cleared Nov 22, 2004
SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
K042314 · FMF
Biogen
General Hospital · 88d
Cleared Nov 19, 2004
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
K042906 · FLL
Amplife Corporation
General Hospital · 29d
Cleared Nov 17, 2004
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
K042980 · FRN
Hospira, Inc.
General Hospital · 19d
Cleared Nov 17, 2004
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K042830 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 35d
Cleared Nov 17, 2004
TIDI BRAND STERILIZATION WRAP
K042580 · FRG
Banta Healthcare Group, Ltd.
General Hospital · 56d
Cleared Nov 10, 2004
PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
K041855 · MSH
Aearo Co.
General Hospital · 124d
Cleared Nov 08, 2004
INNOJECT AUTO-INJECTOR
K042557 · KZH
Innoject, Inc.
General Hospital · 49d
Cleared Nov 08, 2004
BEELINE MOTIV, PROPOLIS, PCA
K042228 · FRN
Mckinley, Inc.
General Hospital · 83d
Cleared Nov 08, 2004
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
K041239 · KZE
Genesis Medical Technology, Inc.
General Hospital · 181d
Cleared Nov 04, 2004
POWDERED VINYL PATIENT EXAMINATION GLOVES
K042120 · LYZ
Shijiazhuang Manful Light Industrial...
General Hospital · 90d
Cleared Nov 03, 2004
POWDER-FREE VINYL PATIENT EXAMINTION GLOVES
K042119 · LYZ
Shijiazhuang Manful Light Industrial...
General Hospital · 89d
Cleared Nov 01, 2004
TRIFUSION, MODEL 0609190/0659350
K041088 · LJS
C.R. Bard, Inc.
General Hospital · 189d
Cleared Oct 29, 2004
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
K041490 · FPA
B.Braun Medical, Inc.
General Hospital · 147d
Cleared Oct 28, 2004
1BD SOLOSHOT IX SYRINGE
K042934 · FMF
Becton, Dickinson & CO
General Hospital · 3d
Cleared Oct 22, 2004
POLYVAC INSTRUMENT DELIVERY SYSTEM
K040223 · KCT
Symmetry Medical USA, Inc.
General Hospital · 263d
Cleared Oct 21, 2004
IV ADMINISTRATION SET B400 SP
K042693 · FPA
Codan US Corp.
General Hospital · 21d
Cleared Oct 18, 2004
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800 · MEA
Hospira, Inc.
General Hospital · 10d
Cleared Oct 18, 2004
EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
K042627 · FLL
Mesure Technology Co., Ltd.
General Hospital · 21d
Cleared Oct 18, 2004
MAXAIR SURGICAL HELMET SYSTEM
K040485 · FYA
Bio-Medical Devices, Inc.
General Hospital · 236d
Cleared Oct 15, 2004
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
K042712 · MEG
Safety Syringes, Inc.
General Hospital · 15d
Cleared Oct 14, 2004
PAINPUMP1
K042405 · FRN
Stryker Corp.
General Hospital · 41d
Cleared Oct 14, 2004
PRESS TACK NEEDLE
K042063 · MQX
Asia-Med GmbH & Co. Kg. - Werk Suhl
General Hospital · 73d
Cleared Oct 14, 2004
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · LHI
B.Braun Medical, Inc.
General Hospital · 157d