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
107665–107688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1994
MEDICAM ENDOCOUPLER AND BEAMSPLITTER
K941693 · GCJ
M.P. Video, Inc.
General & Plastic Surgery · 82d
Cleared Jun 27, 1994
MONOPOLAR COAGULATING POLYPECTOMY SNARE
K941728 · KNS
Endoscopic Innovations, Inc.
Gastroenterology & Urology · 81d
Cleared Jun 27, 1994
KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
K941779 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 27, 1994
O.B. TAMPON
K941863 · HEB
Personal Products Co.
Obstetrics & Gynecology · 73d
Cleared Jun 27, 1994
BIOPSY SCISSORS
K942030 · OCZ
Surgical Technologies, Inc.
Gastroenterology & Urology · 62d
Cleared Jun 27, 1994
URETHRA-BRUSH
K942144 · FDX
Rovers Diagnostic Devices
Gastroenterology & Urology · 55d
Cleared Jun 27, 1994
CURASALT HYPERTONIC SALINE DRESSING
K942459 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 34d
Cleared Jun 24, 1994
STOVALL ENDOMETRIAL BRUSH
K911620 · HFE
Cook Ob/Gyn
Obstetrics & Gynecology · 1170d
Cleared Jun 24, 1994
HYSTEROSCOPE (AND ACCESSORIES)
K921942 · HIH
Optimed Technologies, Inc.
Obstetrics & Gynecology · 791d
Cleared Jun 24, 1994
PHILIPS ENDO-CAVITARY MRI COIL
K930193 · LNH
Philips Medical Systems, Inc.
Radiology · 526d
Cleared Jun 24, 1994
MULTI DOPPLEX II / FETAL DOPPLEX II
K930200 · KNG
Huntleigh Healthcare, Inc.
Radiology · 526d
Cleared Jun 24, 1994
ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI
K932115 · LKF
Blairden Precision Instruments, Inc.
Obstetrics & Gynecology · 417d
Cleared Jun 24, 1994
DERMAL GLOVES
K932953 · LYU
George Glove Company, Inc.
General Hospital · 372d
Cleared Jun 24, 1994
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED
K933056 · IYO
B&K Medical
Radiology · 372d
Cleared Jun 24, 1994
FLIPTIP SAFETY NEEDLE
K933601 · FMI
Syntuition, Inc.
General Hospital · 332d
Cleared Jun 24, 1994
FLUOROFILM(R)
K933800 · EMX
American Custom Medical, Inc.
Ear, Nose, Throat · 324d
Cleared Jun 24, 1994
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION...
K935278 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 233d
Cleared Jun 24, 1994
KARL STORZ URETERO-RENOSCOPE/URETERSCOPE
K940464 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 142d
Cleared Jun 24, 1994
HEARING TECH
K941587 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 85d
Cleared Jun 24, 1994
PHONAK MICROVOX RESONAL FM SYSTEM
K941768 · EPF
Phonak, Inc.
Ear, Nose, Throat · 74d
Cleared Jun 24, 1994
EUROSTAR SUPER, EUROSTAR VFC
K942036 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 24, 1994
AMERICAN CATHETER SPHINCTEROTOME
K942068 · KNS
Intl. Medical, Inc.
Gastroenterology & Urology · 56d
Cleared Jun 24, 1994
FLEXFINDER GUIDEWIRE
K942074 · KNY
Flexmedics
Gastroenterology & Urology · 56d
Cleared Jun 24, 1994
REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
K942244 · ERA
National Custom Ent., Inc.
Ear, Nose, Throat · 87d