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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,808 results
12913–12936 of 17,808
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 28, 1990
AIV SYSTEMS' IV POLES
K895776 · FOX
Automated IV Systems, Inc.
General Hospital · 154d
Cleared Feb 28, 1990
NEEDLE-SHIELD
K900282 · FMI
Macbrud Corp. Medical Div.
General Hospital · 38d
Cleared Feb 28, 1990
IV BIFURCATED EXTENSION SET
K900426 · FPA
Marquette Medical, Inc.
General Hospital · 29d
Cleared Feb 28, 1990
IV TRIFURCATED EXTENSION SET
K900427 · FPA
Marquette Medical, Inc.
General Hospital · 29d
Cleared Feb 27, 1990
LATEX SURGICAL GLOVES
K890019 · LYZ
Argos S.A.
General Hospital · 419d
Cleared Feb 27, 1990
TECNOL LAZER(TM) SURGICAL MASK
K896193 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 125d
Cleared Feb 26, 1990
NOBLES-LAI ENGINEERING INFUSION PUMP
K895688 · DQI
Nobles-Lai Engineering, Inc.
General Hospital · 157d
Cleared Feb 26, 1990
3M IV FLOW REGULATOR
K896907 · LDR
3M Company
General Hospital · 80d
Cleared Feb 23, 1990
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · LZG
Cardiac Pacemakers, Inc.
General Hospital · 36d
Cleared Feb 22, 1990
STERILE SURGEON'S GLOVES (C T R GLOVES)
K895230 · KGO
Tan D. W. Trading Co., Inc.
General Hospital · 191d
Cleared Feb 22, 1990
STEAM STERILIZER (AUTOCLAVE), DENTAL
K895638 · FLE
Porter Instrument Co., Inc.
General Hospital · 156d
Cleared Feb 22, 1990
SHOWER CHAIRS
K895740 · FPO
Lumex, Inc.
General Hospital · 149d
Cleared Feb 16, 1990
SURGICAL GLOVES
K895018 · KGO
Lon Tai Chemical Industrial Co., Ltd.
General Hospital · 192d
Cleared Feb 16, 1990
EXEL SAFELET CATHETER
K895768 · FOZ
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
EXEL HUBER NEEDLE
K895769 · FMI
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
EXEL SPINAL NEEDLES
K895771 · FMI
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
AUTOPEN
K895890 · FMF
Ulster Scientific, Inc.
General Hospital · 134d
Cleared Feb 16, 1990
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
K896935 · FYA
Baxter Healthcare Corp
General Hospital · 65d
Cleared Feb 16, 1990
PORT INFUSION SET (PIS) INFUSION SET (IS)
K897065 · FPA
Prn Services, Inc.
General Hospital · 58d
Cleared Feb 16, 1990
BIO FLOTE(R)
K900131 · FNM
Bio Clinic Co.
General Hospital · 37d
Cleared Feb 15, 1990
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · JOJ
Edward Weck, Inc.
General Hospital · 58d
Cleared Feb 15, 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K897192 · KGO
Baxter Healthcare Corp
General Hospital · 49d
Cleared Feb 13, 1990
LEEDAR (PATIENT EXAMINATION GLOVES - LATEX)
K891663 · LYY
Darchet (Usa), Inc.
General Hospital · 330d
Cleared Feb 13, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892085 · LYY
Howard Associates, Inc.
General Hospital · 316d