FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
116233–116256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1992
BARD STONE REMOVAL BALLOON CATHETER
K920342 · GCA
C.R. Bard, Inc.
Gastroenterology & Urology · 212d
Cleared Aug 26, 1992
MEYER FOREIGN BODY LOCATOR
K920470 · IZH
Seymour W. Meyer
Radiology · 211d
Cleared Aug 26, 1992
BIOSPSY FORCEPS
K920762 · OCZ
Symbiosis Corp.
Gastroenterology & Urology · 189d
Cleared Aug 26, 1992
PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS
K921178 · JAX
Medical Associated Services, Inc.
Anesthesiology · 170d
Cleared Aug 26, 1992
KODAK INSIGHT PORTABLE IMAGING SYSTEM
K921826 · IXA
Eastman Kodak Company
Radiology · 132d
Cleared Aug 26, 1992
MULTI III
K921953 · LIH
Excel Tech. , Ltd.
Neurology · 121d
Cleared Aug 26, 1992
ISOTRON III
K921954 · LIH
Excel Tech. , Ltd.
Neurology · 121d
Cleared Aug 26, 1992
RUBBER FRAME SUNGLASSES
K922508 · HQY
Jedda Dist., Inc.
Ophthalmic · 91d
Cleared Aug 26, 1992
PLATELET AGGREGATION REAGENTS
K922800 · GHR
Chrono-Log Corp.
Hematology · 77d
Cleared Aug 26, 1992
CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE
K922936 · JXG
Clinical Neuro Systems, LLC
Neurology · 69d
Cleared Aug 26, 1992
CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA
K922941 · JXG
Clinical Neuro Systems, LLC
Neurology · 69d
Cleared Aug 26, 1992
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
K923569 · JMO
Baxter Diagnostics, Inc.
Chemistry · 40d
Cleared Aug 26, 1992
STARKEY SM SERIES BTE HEARING AIDS
K923784 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 29d
Cleared Aug 25, 1992
FLLYNN(R) GENESIS AC
K913039 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 413d
Cleared Aug 25, 1992
DISPOSABLE INTUBATION KITS
K921077 · BTR
Coast Medical Corp.
Anesthesiology · 176d
Cleared Aug 25, 1992
FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER
K921697 · KNT
Abbott Laboratories
Gastroenterology & Urology · 139d
Cleared Aug 25, 1992
THE CLEANER ACCESSORY
K921882 · LYL
Eaton Medical Corp.
Ophthalmic · 126d
Cleared Aug 25, 1992
LOOP RETRIEVER
K922678 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Aug 25, 1992
CYTOLOGY BRUSH
K922851 · FDX
Annex Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Aug 25, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K923010 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 64d
Cleared Aug 25, 1992
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
K923317 · JPD
Helena Laboratories
Hematology · 49d
Cleared Aug 25, 1992
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
K923318 · JPD
Helena Laboratories
Hematology · 49d
Cleared Aug 24, 1992
TEC ROTATING DUAL HEMOVALVE
K912664 · DYB
Intensive Technology, Inc.
Cardiovascular · 433d
Cleared Aug 24, 1992
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
K915270 · MEA
Graseby Medical , Ltd.
General Hospital · 273d