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
7921–7944 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 31, 2000
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH...
K002176 · LYY
Sgmp Co., Ltd.
General Hospital · 12d
Cleared Jul 28, 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP...
K002211 · FRN
Baxter Healthcare Corp
General Hospital · 7d
Cleared Jul 27, 2000
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
K000050 · LYY
Top Quality Mfg., Inc.
General Hospital · 202d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616 · FOZ
Abbott Laboratories
General Hospital · 63d
Cleared Jul 27, 2000
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS...
K001739 · LYY
Allegiance Healthcare Corp.
General Hospital · 49d
Cleared Jul 27, 2000
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES
K002192 · KGO
Ansell Perry
General Hospital · 7d
Cleared Jul 26, 2000
MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
K001497 · LZA
Multisafe Sdn. Bhd.
General Hospital · 72d
Cleared Jul 26, 2000
MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
K001619 · LZA
Multisafe Sdn. Bhd.
General Hospital · 62d
Cleared Jul 26, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
K001836 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 40d
Cleared Jul 26, 2000
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM...
K001959 · KGO
Hartalega Sdn Bhd
General Hospital · 29d
Cleared Jul 26, 2000
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
K002033 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 21d
Cleared Jul 25, 2000
ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH...
K001375 · LZA
Best Manufacturing Company
General Hospital · 85d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
K001423 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
K001424 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d
Cleared Jul 21, 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
K001426 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 77d
Cleared Jul 20, 2000
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · FRN
Abbott Laboratories
General Hospital · 6d
Cleared Jul 17, 2000
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · MEG
Univec, Inc.
General Hospital · 236d
Cleared Jul 14, 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K001924 · KGO
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Jul 13, 2000
ISOLETTE INFANT INCUBATOR, MODEL C2HS
K001242 · FMZ
Hill-Rom Air-Shields
General Hospital · 86d
Cleared Jul 11, 2000
KLINIDRAPE REINFORCED SURGICAL GOWNS
K000902 · FYA
Molnlycke Health Care, Inc.
General Hospital · 112d
Cleared Jul 11, 2000
NEEDLELESS TRANSFER DEVICE
K001831 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 25d
Cleared Jul 11, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
K001837 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 25d
Cleared Jul 11, 2000
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K001861 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 22d
Cleared Jul 11, 2000
SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
K001863 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 22d