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
121633–121656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 24, 1991
L582 TRANSDUCER
K904600 · MAA
Acuson Corp.
Radiology · 257d
Cleared Jun 24, 1991
BARD ALFENTANIL INFUSER
K904890 · FRN
C.R. Bard, Inc.
General Hospital · 237d
Cleared Jun 24, 1991
TMP MANDIBULAR COMPRESSION SYSTEM
K905024 · HRS
Techmedica, Inc.
Orthopedic · 229d
Cleared Jun 24, 1991
MTS KNEE SYSTEM
K905613 · JWH
T & R Mfg., Inc.
Orthopedic · 192d
Cleared Jun 24, 1991
SEAL-RITE SILICONE EAR PLUG
K910177 · EWD
Flents Products Co., Inc.
Ear, Nose, Throat · 160d
Cleared Jun 24, 1991
POCKET DOP 3
K910462 · HEP
Imex Medical Systems, Inc.
Radiology · 140d
Cleared Jun 24, 1991
VISUWELL SYPHILIS ANTIGEN
K910487 · LIP
Adi Diagnostics, Inc.
Microbiology · 138d
Cleared Jun 24, 1991
HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY
K910602 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 131d
Cleared Jun 24, 1991
COLOR VUE TM- MYCOPLASMA PNEUMONIAE
K910833 · GSA
Seradyn, Inc.
Microbiology · 117d
Cleared Jun 24, 1991
MOSS- ANCHOR SET
K910910 · KNT
Moss Medical Products
Gastroenterology & Urology · 111d