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
102457–102480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1995
CONTRAST 7000 THERAPY SYSTEM
K943497 · ILO
Burke Neutech, Inc.
Physical Medicine · 323d
Cleared Jun 07, 1995
SONICAID MODEL MR-63 AMBULATORY ECG RECORDER
K943862 · DSH
Oxford Instruments Medical Systems
Cardiovascular · 303d
Cleared Jun 07, 1995
GRAHAM-FIELD ULTRASOUND LOTION
K944596 · IMI
Chester Labs, Inc.
Radiology · 261d
Cleared Jun 07, 1995
HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE
K944905 · BSP
Holgrath Medical Technologies, Inc.
Anesthesiology · 245d
Cleared Jun 07, 1995
HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE
K944906 · BSP
Holgrath Medical Technologies, Inc.
Anesthesiology · 245d
Cleared Jun 07, 1995
HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE
K944907 · BSP
Holgrath Medical Technologies, Inc.
Anesthesiology · 245d
Cleared Jun 07, 1995
HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE
K944908 · BSP
Holgrath Medical Technologies, Inc.
Anesthesiology · 245d
Cleared Jun 07, 1995
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
K945748 · DHB
Hycor Biomedical, Inc.
Immunology · 196d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
K946157 · LSE
Incstar Corp.
Microbiology · 181d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159 · LSE
Incstar Corp.
Microbiology · 181d
Cleared Jun 07, 1995
ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
K946237 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 167d
Cleared Jun 07, 1995
PEREGRINE DIFFUSION LIGHT PIPE
K950529 · HJM
Peregrine Surgical , Ltd.
Ophthalmic · 120d
Cleared Jun 07, 1995
ULTIMA AUGMENTED UHMWPE CUP
K950563 · KWL
Johnson & Johnson Professionals, Inc.
Orthopedic · 119d
Cleared Jun 07, 1995
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
K951043 · BSJ
Promedic, Inc.
Anesthesiology · 92d
Cleared Jun 07, 1995
VH-2000
K951323 · INQ
Health Care Mfg., Inc.
Physical Medicine · 76d
Cleared Jun 07, 1995
MRI'S ALL SILICONE GASTROSTOMY TUBE
K951489 · KNT
Manufacturing & Research, Inc.
Gastroenterology & Urology · 68d
Cleared Jun 07, 1995
HI SONIC 2000 DIGITAL HEARING INSTRUMENT
K951678 · LXB
Hearing Innovations, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 07, 1995
HUMID-VENT MICRO
K951856 · BYD
Gibeck, Inc.
Anesthesiology · 47d
Cleared Jun 07, 1995
NASAL SEPTAL SPLINT
K952207 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 06, 1995
NATURAL-KNEE(R)/APOLLO(TM) KNEE
K935523 · JWH
Intermedics Orthopedics
Orthopedic · 565d
Cleared Jun 06, 1995
OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
K941366 · MEH
Osteonics Corp.
Orthopedic · 442d
Cleared Jun 06, 1995
ELITE BIOFEEDBACK
K942563 · HIR
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 371d
Cleared Jun 06, 1995
NEPHRO-URETERAL STENT
K942688 · LJE
Uresil Corp.
Gastroenterology & Urology · 364d
Cleared Jun 06, 1995
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
K944999 · JJX
More Diagnostics
Chemistry · 236d