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
7465–7488 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 21, 2001
PRE-POWDERED NITRILE EXAMINATION GLOVES
K010232 · LZA
P.T. Healthcare Glovindo
General Hospital · 240d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED...
K012857 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING...
K012860 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 21, 2001
NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN...
K012863 · LYY
Sgmp Co., Ltd.
General Hospital · 28d
Cleared Sep 19, 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · FMF
Orthovita, Inc.
General Hospital · 162d
Cleared Sep 19, 2001
HORIZON OUTLOOK WITH DOSECOM
K011975 · FRN
B.Braun Medical, Inc.
General Hospital · 86d
Cleared Sep 19, 2001
BIFURCATED VACCINATING NEEDLE
K012515 · SCL
Precision Medical Products, Inc.
General Hospital · 44d
Cleared Sep 18, 2001
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168 · KKX
Advance Medical Designs, Inc.
General Hospital · 68d
Cleared Sep 18, 2001
DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K012711 · LYZ
Shijiazhuang Brilliance Plastic Co.,...
General Hospital · 35d
Cleared Sep 18, 2001
GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
K012899 · LZA
Best Manufacturing Company
General Hospital · 20d
Cleared Sep 17, 2001
INFARED EAR THERMOMETER, MODEL TH8 SERIES
K011059 · FLL
Radiant Innovation, Inc.
General Hospital · 164d
Cleared Sep 17, 2001
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
K011613 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 115d
Cleared Sep 17, 2001
CLINCARE LATEX SURGEON'S GLOVE
K012067 · KGO
Ttk Healthcare , Ltd.
General Hospital · 77d
Cleared Sep 17, 2001
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN...
K012558 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 40d
Cleared Sep 14, 2001
ALLERSHARP ALLERGY SKIN TESTER
K011979 · SCL
Hmb Medical Concepts, Ltd.
General Hospital · 81d
Cleared Sep 14, 2001
BIOTEQUE SCALP VEIN SET
K012526 · FPA
Bioteque Corp.
General Hospital · 39d
Cleared Sep 14, 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845 · FPA
Sterling Medivations, Inc.
General Hospital · 22d
Cleared Sep 12, 2001
MEDFUSION 2001 & 2010, MODEL N7215IWC
K012259 · MRZ
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 12, 2001
BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
K012262 · MRZ
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 12, 2001
SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
K012266 · MRZ
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 11, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS...
K011045 · LYY
Shen Wei (Usa), Inc.
General Hospital · 159d
Cleared Sep 11, 2001
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM...
K011066 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 155d
Cleared Sep 11, 2001
HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011242 · MQX
Acusupply, Inc.
General Hospital · 141d
Cleared Sep 11, 2001
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50...
K011407 · LYY
Sempermed USA, Inc.
General Hospital · 145d