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
102073–102096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1995
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K950816 · CGA
Lifescan, Inc.
Chemistry · 131d
Cleared Jul 03, 1995
PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS
K951144 · KPS
GE Medical Systems
Radiology · 112d
Cleared Jul 03, 1995
LMT BONE ANCHOR
K951233 · HWC
Li Medical Technologies, Inc.
Orthopedic · 105d
Cleared Jul 03, 1995
OPUS PROCAINAMIDE
K951434 · LAR
Behring Diagnostics, Inc.
Toxicology · 97d
Cleared Jul 03, 1995
LMT BONE ANCHOR
K951472 · HWC
Li Medical Technologies, Inc.
Orthopedic · 95d
Cleared Jul 03, 1995
OGDEN ANCHOR
K951493 · HWC
American Medical Electronics, Inc.
Orthopedic · 94d
Cleared Jul 03, 1995
SUCTION CATHETER KIT, STERILE, SINGLE-USE
K951506 · BSY
Trinity Laboratories, Inc.
Anesthesiology · 91d
Cleared Jul 03, 1995
OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS
K951545 · HWC
American Medical Electronics, Inc.
Orthopedic · 95d
Cleared Jul 03, 1995
ACUTEK'S CLEARPASSAGE
K951644 · LWF
Acutek Adhesive Specialties, Inc.
Ear, Nose, Throat · 84d
Cleared Jul 03, 1995
KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING
K952081 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 61d
Cleared Jul 03, 1995
AMERLITE FSH ASSAY
K952285 · CGJ
Johnson & Johnson Clinical...
Chemistry · 48d
Cleared Jul 03, 1995
V40 ZIRCONIA FEMORAL HEADS
K952418 · LZO
Howmedica Corp.
Orthopedic · 41d
Cleared Jul 03, 1995
INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)
K952505 · CFL
Nichols Institute
Chemistry · 33d
Cleared Jul 03, 1995
RICHARDS TORP
K952549 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 31d
Cleared Jul 03, 1995
PHILIPS EASYVISION
K952704 · IZI
Philips Medical Systems, Inc.
Radiology · 19d
Cleared Jul 03, 1995
LORI-A
K952711 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 19d
Cleared Jun 30, 1995
COMPUSPEAK
K941566 · LLZ
Hogan & Hartson
Radiology · 455d
Cleared Jun 30, 1995
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · KGS
Acufex Microsurgical, Inc.
General & Plastic Surgery · 449d
Cleared Jun 30, 1995
GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES
K941973 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 434d
Cleared Jun 30, 1995
GERTIE MARX EPI-SPINAL TRAY
K943319 · CAZ
Spinal Specialties, Inc.
Anesthesiology · 354d
Cleared Jun 30, 1995
TORCARS,CANNULAE,SHEATHS,OBTURATORS
K943713 · HET
Karl Storz Endoskop GmbH
Obstetrics & Gynecology · 333d
Cleared Jun 30, 1995
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K944029 · CAZ
Spinal Specialties, Inc.
Anesthesiology · 317d
Cleared Jun 30, 1995
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
K944219 · DTR
Gish Biomedical, Inc.
Cardiovascular · 305d
Cleared Jun 30, 1995
SPECIFIC IGE ULTRA-EIA
K945884 · DHB
Hycor Biomedical, Inc.
Immunology · 211d