FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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 · Free access · No registration required

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175,820 results
126481–126504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1990
FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)
K900127 · KMF
Ferris Mfg. Corp.
General & Plastic Surgery · 129d
Cleared May 18, 1990
IN-THE NEBULIZER
K900470 · CAF
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 107d
Cleared May 18, 1990
SYRINGE DISPOSAL SYSTEM
K900687 · FMF
National Syringe Disposal, Inc.
General Hospital · 94d
Cleared May 18, 1990
VISI-SORB ABSORBANT STICK
K900786 · HOZ
Visitec Co.
Ophthalmic · 87d
Cleared May 18, 1990
WHEELED STRETCHER
K900872 · FPO
Hospital Supply Co., Inc.
General Hospital · 81d
Cleared May 18, 1990
PEDIATRIC HOSPITAL BED
K900873 · FMS
Hospital Supply Co., Inc.
General Hospital · 81d
Cleared May 18, 1990
IN-LINE VIAL CONNECTION SITE
K900909 · FPA
Baxter Healthcare Corp
General Hospital · 80d
Cleared May 18, 1990
PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL
K900929 · HQX
Oculo Plastik, Inc.
Ophthalmic · 80d
Cleared May 18, 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
K901078 · BTO
L H M Ent., Inc.
Anesthesiology · 72d
Cleared May 18, 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
K901079 · BTO
L H M Ent., Inc.
Anesthesiology · 72d
Cleared May 18, 1990
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K901119 · BSZ
Ohmeda Medical
Anesthesiology · 67d
Cleared May 18, 1990
LIFE AID RESUSCITATOR
K901218 · BTM
Clarendon Supplies , Ltd.
Anesthesiology · 65d
Cleared May 18, 1990
AMICON HEMOCONCENTRATOR SET
K901286 · KDI
Amicon, Inc.
Gastroenterology & Urology · 59d
Cleared May 18, 1990
HGP II TOTAL HIP FEMERAL STEM
K901364 · JDI
Zimmer, Inc.
Orthopedic · 56d
Cleared May 18, 1990
LATEX PATIENT EXAMINATION GLOVE
K901855 · LYY
Tower Marketing Sdn. Bhd.
General Hospital · 24d
Cleared May 18, 1990
PATIENT EXAMINATION GLOVES
K901903 · LYY
Southland Products Co., Ltd.
General Hospital · 21d
Cleared May 18, 1990
LATEX PATIENT EXAMINATION GLOVES
K902017 · LYY
Taksin Rubber Industries Co., Ltd.
General Hospital · 15d
Cleared May 18, 1990
HEMAGEN ENA [JO-I] KIT
K902139 · DHN
Hemagen Diagnostics, Inc.
Immunology · 9d
Cleared May 17, 1990
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
K896020 · DTR
Gish Biomedical, Inc.
Cardiovascular · 213d
Cleared May 17, 1990
VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA
K896338 · DWF
Voss Medical Products
Cardiovascular · 195d
Cleared May 17, 1990
PCI MODEL 2041-B TELEMETRY MONITOR
K896775 · DSI
Accucore, Inc.
Cardiovascular · 167d
Cleared May 17, 1990
MODEL 215M PATIENT SIMULATOR
K897074 · DSI
Dynatech/Nevada, Inc.
Cardiovascular · 146d
Cleared May 17, 1990
MICROPLATE REAGENT DISPENSER
K900599 · JQW
Denley Instruments, Inc.
Chemistry · 98d
Cleared May 17, 1990
HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
K900758 · DTM
Cobe Laboratories, Inc.
Cardiovascular · 90d