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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121033–121056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1991
VS11
K912300 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
STANDARD S1
K912303 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
STANDARD S2
K912304 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
STANDARD S4
K912306 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
STANDARD S33
K912309 · EJS
Metalor Dental USA Corp.
Dental · 36d
Cleared Jun 26, 1991
PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
K912570 · ESD
Phonak, Inc.
Ear, Nose, Throat · 15d
Cleared Jun 26, 1991
PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT
K912571 · ESD
Phonak, Inc.
Ear, Nose, Throat · 15d
Cleared Jun 25, 1991
SLIMCATH (TM)
K903001 · HIT
Gynopharma, Inc.
Ophthalmic · 351d
Cleared Jun 25, 1991
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · BXN
Utah Medical Products, Inc.
Anesthesiology · 223d
Cleared Jun 25, 1991
TURBO SUPPORT CATHETER
K910116 · DQY
Datascope Corp.
Cardiovascular · 166d
Cleared Jun 25, 1991
SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
K910769 · ODD
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 123d
Cleared Jun 25, 1991
MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE
K911099 · DWX
Pilling Co.
Cardiovascular · 105d
Cleared Jun 25, 1991
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
K911298 · BTM
Intertech Resources, Inc.
Anesthesiology · 92d
Cleared Jun 25, 1991
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
K911384 · DXK
Endosonics Corp.
Cardiovascular · 89d
Cleared Jun 25, 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Jun 25, 1991
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
K911721 · HKX
Keeler Instruments, Inc.
Ophthalmic · 69d
Cleared Jun 25, 1991
GEMINI OPHTHALMIC SURGERY SYSTEM
K911808 · HQC
Alcon Laboratories
Ophthalmic · 63d
Cleared Jun 25, 1991
DELFIA(R) 17 -OH-PROGESTERON KIT
K912026 · JLX
Pharmacia Diagnostics, Inc.
Hematology · 49d
Cleared Jun 25, 1991
MAINSTER HIGH MAGNIFICATION LASER LENS
K912366 · HJK
Ocular Instruments, Inc.
Ophthalmic · 27d
Cleared Jun 24, 1991
BIOVISION EMERALD LASER PHOTOCOAGULATOR
K895363 · GEX
F.I.T. of France
General & Plastic Surgery · 665d
Cleared Jun 24, 1991
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
K901552 · EJH
Nobelpharma USA, Inc.
Dental · 447d
Cleared Jun 24, 1991
LATERALASE TM
K903418 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 328d
Cleared Jun 24, 1991
CROATEST (R) RHEUMATOID DIAGNOSTIC
K904416 · GTQ
Biotrax, Inc.
Microbiology · 270d
Cleared Jun 24, 1991
SONO-VU US(TM)
K904583 · HIO
E-Z-Em, Inc.
Radiology · 258d