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
86185–86208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1999
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
K990050 · FGB
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 78d
Cleared Mar 26, 1999
GLIADIN IGG ELISA TEST SYSTEM
K990204 · MST
Zeus Scientific, Inc.
Immunology · 64d
Cleared Mar 26, 1999
DIGISCOPE OPHTHALMIC CAMERA
K990205 · HKI
Eye Tel Imaging, Inc.
Ophthalmic · 64d
Cleared Mar 26, 1999
GLIADIN IGA ELISA TEST SYSTEM
K990207 · MST
Zeus Scientific, Inc.
Immunology · 64d
Cleared Mar 26, 1999
DUODERM HYDROACTIVE GEL WOUND DRESSING
K990368 · MGQ
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 46d
Cleared Mar 26, 1999
ESOPHAGEAL INTUBATION DETECTOR
K990556 · BTR
Wolfe Tory Medical, Inc.
Anesthesiology · 32d
Cleared Mar 26, 1999
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
K990657 · MNH
Corin USA
Orthopedic · 25d
Cleared Mar 26, 1999
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
K990685 · JWY
Ab Biodisk
Microbiology · 23d
Cleared Mar 26, 1999
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
K990687 · PKL
Olympus Optical, Co.
Gastroenterology & Urology · 25d
Cleared Mar 26, 1999
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN...
K990786 · LAG
Princeton BioMeditech Corp.
Toxicology · 16d
Cleared Mar 26, 1999
C1 ULTRASOUND SYSTEM
K990806 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Mar 25, 1999
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798 · KWQ
Osteonics Corp.
Orthopedic · 227d
Cleared Mar 25, 1999
BCI MINI-TORR PLUS, MODEL 6004
K984618 · DXN
Bci Intl., Inc.
Cardiovascular · 86d
Cleared Mar 25, 1999
JELDENT MULTICRYL
K990056 · EBI
J.F. Jelenko & Co., Inc.
Dental · 77d
Cleared Mar 25, 1999
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND...
K990072 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 73d
Cleared Mar 25, 1999
NORMED BONE TRANSPORT
K990140 · JEY
Ace Surgical Supply Co., Inc.
Dental · 65d
Cleared Mar 25, 1999
WILSON-COOK BIPOLAR PROBE
K990145 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 25, 1999
PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT
K990208 · MEG
Science Incorporated
General Hospital · 63d
Cleared Mar 25, 1999
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257 · HKX
Keeler Instruments, Inc.
Ophthalmic · 57d
Cleared Mar 25, 1999
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND...
K990438 · MGP
Dermaphylyx, Inc.
General & Plastic Surgery · 42d
Cleared Mar 25, 1999
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
K990456 · KPI
Hollister, Inc.
Gastroenterology & Urology · 41d
Cleared Mar 25, 1999
PEREGRINE WET SET, MODEL PD400.00
K990518 · FRN
Peregrine Surgical , Ltd.
General Hospital · 35d
Cleared Mar 25, 1999
IGG FLEX REAGENT CARTRIDGE
K990551 · CFQ
Dade Behring, Inc.
Immunology · 31d
Cleared Mar 25, 1999
IMMUNOGLOBULIN A TEST SYSTEM
K990552 · CFQ
Dade Behring, Inc.
Immunology · 31d