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
111193–111216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1994
PNEUMATIC WIRE TENSIONER
K934431 · HSZ
Smith & Nephew Richards, Inc.
Orthopedic · 136d
Cleared Jan 27, 1994
SANDMAN
K934599 · OLV
Melville Software , Ltd.
Neurology · 125d
Cleared Jan 27, 1994
MAS LIQUID URINALYSIS CONTROL
K935062 · JJW
Medical Analysis Systems, Inc.
Chemistry · 99d
Cleared Jan 27, 1994
URINE CALIBRATORS AND CONTROLS MODIFICATION
K935101 · DKB
Diagnostic Reagents, Inc.
Toxicology · 99d
Cleared Jan 27, 1994
ASPARTATE AMINOTRANSFERASE (AST) TEST
K935181 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Jan 27, 1994
CENTRIFIQ BLOOD CONTROL
K935343 · JPK
Hematronix, Inc.
Hematology · 128d
Cleared Jan 27, 1994
P-AMYLASE CONTROL
K935362 · JJX
Beckman
Chemistry · 84d
Cleared Jan 27, 1994
SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING
K935501 · LIT
Scimed Peripheral Interventions
Cardiovascular · 72d
Cleared Jan 27, 1994
EVENT TEST STRIP HCG
K935502 · JHI
Boehringer Mannheim Italia Spa
Chemistry · 72d
Cleared Jan 27, 1994
SNAP DRILL
K935516 · HWE
Surgiquip, Inc.
Orthopedic · 70d
Cleared Jan 27, 1994
HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000
K935559 · ESD
Rockwin Corp.
Ear, Nose, Throat · 71d
Cleared Jan 27, 1994
LSPI PRESSURE REGULATOR
K936187 · CAN
Life Support Products, Inc.
Anesthesiology · 35d
Cleared Jan 26, 1994
VARIOUS KITS AND TRAYS
K920292 · LRO
Professional Medical Products, Inc.
General & Plastic Surgery · 735d
Cleared Jan 26, 1994
FLEXI-FLOW CEMENT NATURAL
K922249 · EMA
Essential Dental Systems, Inc.
Dental · 630d
Cleared Jan 26, 1994
FLEXI-FLOW CEMENT WITH TITANIUM
K922250 · EMA
Essential Dental Systems, Inc.
Dental · 630d
Cleared Jan 26, 1994
TI-CORE-NATURAL
K922251 · EBF
Essential Dental Systems, Inc.
Dental · 630d
Cleared Jan 26, 1994
TI-CORE NEW & IMPROVED
K922252 · EBF
Essential Dental Systems, Inc.
Dental · 630d
Cleared Jan 26, 1994
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
K924608 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 502d
Cleared Jan 26, 1994
FORESTADENT ORTHODONTIC BANDS
K925028 · EJF
Forestadent
Dental · 481d
Cleared Jan 26, 1994
DENTAL LIGHT
K926081 · EAZ
Mdt Corp., Inc.
Dental · 421d
Cleared Jan 26, 1994
FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE
K926262 · BXB
Sgarlato Laboratories, Inc.
Physical Medicine · 404d
Cleared Jan 26, 1994
ARTHREX INSTRUMENTS (WRIST)
K926303 · HRX
Arthrex, Inc.
Orthopedic · 407d
Cleared Jan 26, 1994
LARIAT PALATE EXPANDER
K926427 · EJF
Easy Access Orthodontics, Inc.
Dental · 399d
Cleared Jan 26, 1994
BONE SAW BLADES
K931176 · HWE
Betzler Mfg., Inc.
Orthopedic · 323d