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
8329–8352 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 10, 1999
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
K992358 · LYY
Biopro (M) Sdn Bhd
General Hospital · 58d
Cleared Sep 10, 1999
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
K992588 · LZA
Formosa Glove Industrial Co., Ltd.
General Hospital · 39d
Cleared Sep 09, 1999
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH...
K991969 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 90d
Cleared Sep 09, 1999
PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
K992091 · FMI
Bio-Plexus, Inc.
General Hospital · 80d
Cleared Sep 09, 1999
TERUMO U-100 INSULIN SYRINGE
K992802 · FMF
Terumo Medical Corp.
General Hospital · 21d
Cleared Sep 08, 1999
INFUSION DYNAMICS POWER INFUSER MODEL M100B
K992044 · FRN
Infusion Dynamics, Inc.
General Hospital · 83d
Cleared Sep 07, 1999
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992170 · LZA
Best Manufacturing Company
General Hospital · 71d
Cleared Sep 03, 1999
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
K991979 · FPA
Medtronic Minimed
General Hospital · 81d
Cleared Sep 02, 1999
SAGE CONTRAST MANAGEMENT SYSTEM
K991112 · FPA
Sage Laboratories, Inc.
General Hospital · 154d
Cleared Aug 31, 1999
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50...
K991777 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 98d
Cleared Aug 31, 1999
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
K991778 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 98d
Cleared Aug 31, 1999
MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
K991904 · FMI
Jms Co., Ltd.
General Hospital · 88d
Cleared Aug 30, 1999
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
K990310 · CAK
Charter Medical, Ltd.
General Hospital · 210d
Cleared Aug 30, 1999
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
K991437 · FRN
Wells Johnson Co.
General Hospital · 126d
Cleared Aug 30, 1999
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH...
K992162 · LZC
Safeskin Corp.
General Hospital · 66d
Cleared Aug 30, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE
K992223 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 60d
Cleared Aug 30, 1999
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992463 · LYZ
Shijiazhuang Dilly Plastics Products...
General Hospital · 38d
Cleared Aug 27, 1999
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · MQX
Sedatelec
General Hospital · 303d
Cleared Aug 27, 1999
DN ACUPUNTURE NEEDLES
K983800 · MQX
Sedatelec
General Hospital · 303d
Cleared Aug 27, 1999
KANGNIAN BRAND ACUPUNCTURE NEEDLE
K991507 · MQX
Helio Medical Supplies, Inc.
General Hospital · 120d
Cleared Aug 27, 1999
ACUMASTER BRAND ACUPUNCTURE NEEDLE
K991508 · MQX
Helio Medical Supplies, Inc.
General Hospital · 120d
Cleared Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
K992198 · FOZ
Cook, Inc.
General Hospital · 58d
Cleared Aug 25, 1999
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · FRG
Allegiance Healthcare Corp.
General Hospital · 308d
Cleared Aug 25, 1999
MED-RX EXTENSION SETS
K990777 · FPA
Benlan, Inc.
General Hospital · 169d