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
110281–110304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1994
SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
K932653 · LGH
Carapace, Inc.
Orthopedic · 240d
Cleared Jan 28, 1994
THERMAL OPTION
K932790 · KGE
Cox Medical Ent., Inc.
Gastroenterology & Urology · 233d
Cleared Jan 28, 1994
CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO
K932826 · EBF
Alpha-Dent
Dental · 233d
Cleared Jan 28, 1994
CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST
K932829 · EBF
Alpha-Dent
Dental · 233d
Cleared Jan 28, 1994
GUARDIAN AND ANDINO MODELS
K932991 · FLK
Coltemp, Inc.
General Hospital · 224d
Cleared Jan 28, 1994
SOFAMOR ORTHOPAEDIC INSTRUMENTS
K933242 · LXH
Danek Medical, Inc.
Orthopedic · 210d
Cleared Jan 28, 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712 · DHR
Theratest Laboratories, Inc.
Immunology · 182d
Cleared Jan 28, 1994
MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
K933726 · LHC
Augustine Medical, Inc.
General Hospital · 179d
Cleared Jan 28, 1994
ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR
K933832 · FLL
Electromedics, Inc.
General Hospital · 176d
Cleared Jan 28, 1994
N-ASSAY TIA MULTI V-NL
K933973 · CFN
Crestat Diagnostics, Inc.
Immunology · 168d
Cleared Jan 28, 1994
PROFIBLOT
K933996 · KPA
Tecan U.S., Ltd.
Pathology · 164d
Cleared Jan 28, 1994
AC-POWERED MEDICAL EXAMINATION LIGHT
K934259 · KZF
Welch Allyn, Inc.
General Hospital · 150d
Cleared Jan 28, 1994
MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY
K934526 · CAZ
Neurodelivery Technology, Inc.
Anesthesiology · 130d
Cleared Jan 28, 1994
LORAD M-III
K934625 · IZH
Lorad Corp.
Radiology · 123d
Cleared Jan 28, 1994
OLYMPUS IMAGEMANAGER SYSTEM
K934889 · LMB
Olympus
Radiology · 107d
Cleared Jan 28, 1994
FULL VIEW DIGITAL STORAGE SYSTEM
K934908 · IYO
International Imaging Electronics
Radiology · 107d
Cleared Jan 28, 1994
RABBIT KIDNEY CELLS - R.K.C.
K934934 · KIR
Advanced Clinical Diagnostics
Pathology · 155d
Cleared Jan 28, 1994
HELA-229/HELA CELLS
K934973 · KIR
Advanced Clinical Diagnostics
Pathology · 102d
Cleared Jan 28, 1994
SNAP BONE REAMER
K935322 · HWE
Surgiquip, Inc.
Orthopedic · 85d
Cleared Jan 28, 1994
SNAP RECIPROCATING SAW
K935357 · GAF
Surgiquip, Inc.
General & Plastic Surgery · 85d
Cleared Jan 28, 1994
MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS
K935480 · FMI
Evans Medical, Inc.
General Hospital · 95d
Cleared Jan 28, 1994
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
K935528 · DBF
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 73d
Cleared Jan 28, 1994
0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS
K935641 · FPB
Evans Medical, Inc.
General Hospital · 67d
Cleared Jan 28, 1994
EVANS MEDICAL EXTENSION SETS
K935642 · FPK
Evans Medical, Inc.
General Hospital · 67d