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
7105–7128 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 06, 2002
POWDER FREE NITRILE EXAMINATION GLOVES
K022619 · LZA
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 30d
Cleared Sep 05, 2002
DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E
K022368 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 45d
Cleared Sep 05, 2002
MEDRAD TRANSFER SET
K022431 · FPK
Medrad, Inc.
General Hospital · 42d
Cleared Sep 05, 2002
POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN...
K022442 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 42d
Cleared Sep 05, 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
K022502 · KZE
Equidyne Systems, Inc.
General Hospital · 38d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
K022088 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
K022090 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K022092 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
K022146 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Aug 30, 2002
DATEX-OHMEDA HMEF 500
K021265 · CAH
Datex-Ohmeda
General Hospital · 130d
Cleared Aug 29, 2002
NONCOR INFUSION SETS
K021080 · FPA
Cardio Med Supplies, Inc.
General Hospital · 148d
Cleared Aug 29, 2002
HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
K021916 · FPA
Harmac Medical Products, Inc.
General Hospital · 79d
Cleared Aug 29, 2002
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
K021988 · FRN
Medrad, Inc.
General Hospital · 72d
Cleared Aug 29, 2002
SAFEPRO SAFETY SYRINGE
K022063 · MEG
Formosa Medical Devices, Inc.
General Hospital · 65d
Cleared Aug 29, 2002
FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
K022260 · LGM
Isolation Systems, Inc.
General Hospital · 62d
Cleared Aug 28, 2002
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · FRG
Advanced Sterilization Products
General Hospital · 356d
Cleared Aug 28, 2002
INTROCAN SAFETY IV CATHETER
K020785 · FOZ
B.Braun Medical, Inc.
General Hospital · 170d
Cleared Aug 26, 2002
POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)
K022530 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 26d
Cleared Aug 26, 2002
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 21d
Cleared Aug 22, 2002
ARTERIA BLOOD FILTER
K021293 · FPB
Arteria Medical Science, Inc.
General Hospital · 121d
Cleared Aug 22, 2002
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION...
K022102 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 55d
Cleared Aug 21, 2002
SURE-LOK
K021315 · FMI
Vital Signs, Inc.
General Hospital · 118d
Cleared Aug 21, 2002
PERFUSOR COMPACT WITH FM SYSTEM
K022575 · FRN
B.Braun Medical, Inc.
General Hospital · 19d
Cleared Aug 20, 2002
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
K012931 · FRG
Allegiance Healthcare Corp.
General Hospital · 354d