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
99673–99696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1995
IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM
K952490 · LJM
Roche Image Analysis Systems
Immunology · 199d
Cleared Dec 15, 1995
KENTEMP
K953465 · FLK
Kentron Health Care, Inc.
General Hospital · 144d
Cleared Dec 15, 1995
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
K953866 · DXY
Medtronic Vascular
Cardiovascular · 127d
Cleared Dec 15, 1995
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
K954092 · DXY
Medtronic Vascular
Cardiovascular · 127d
Cleared Dec 15, 1995
AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES
K954316 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 91d
Cleared Dec 15, 1995
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · FIP
Minntech Corp.
Gastroenterology & Urology · 88d
Cleared Dec 15, 1995
T CLASS HYPERBARIC FACILITIES
K954387 · CBF
Reimers Systems, Inc.
Anesthesiology · 118d
Cleared Dec 15, 1995
PER-Q-CATH MID-LINE
K954422 · LJS
Gesco Intl., Inc.
General Hospital · 85d
Cleared Dec 15, 1995
AIA-PACK CORT ASSAY
K954591 · JFT
Tosoh Medics, Inc.
Chemistry · 74d
Cleared Dec 15, 1995
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
K954700 · LKJ
Helix Diagnostics, Inc.
Immunology · 64d
Cleared Dec 15, 1995
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
K954723 · LKJ
Helix Diagnostics, Inc.
Immunology · 63d
Cleared Dec 15, 1995
SIMS DELTEC ANTI-SIPHON VALVE
K954870 · FPA
Sims Deltec, Inc.
General Hospital · 52d
Cleared Dec 15, 1995
SQUARE ONE SAFETY SYRINGE
K955030 · MEG
Square One Medical, LP
General Hospital · 43d
Cleared Dec 15, 1995
OLYMPUS FG-45/46-1 GRASPING FORCEPS
K955049 · FFL
Olympus America, Inc.
Gastroenterology & Urology · 39d
Cleared Dec 15, 1995
DISPOSABLE POWDER FREE VINYL SYNTHETIC GLOVES
K955091 · LYZ
Safehealth Medical Supply Corp.
General Hospital · 38d
Cleared Dec 14, 1995
ELECTRONIC FLOW METER
K943678 · BZH
Vitalograph, Inc.
Anesthesiology · 506d
Cleared Dec 14, 1995
ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
K953826 · GOM
Pyramid Biological Corp.
Microbiology · 121d
Cleared Dec 14, 1995
MASTERSCREEN IOS
K954140 · BZG
Erich Jaeger GmbH & Co. KG
Anesthesiology · 104d
Cleared Dec 14, 1995
STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
K954340 · HQC
Storz
Ophthalmic · 87d
Cleared Dec 14, 1995
OLYMPIC SMART SCALE
K954846 · FRW
Olympic Medical Corp.
General Hospital · 52d
Cleared Dec 14, 1995
HANYANG SUNGLASSES
K955127 · HQY
Hanyang Industries, Inc.
Ophthalmic · 35d
Cleared Dec 14, 1995
OLYMPIC SMART SCALE
K955177 · FRW
Olympic Medical Corp.
General Hospital · 31d
Cleared Dec 13, 1995
APR ACETABULAR INSERTS IOI BIPOLAR
K935585 · JDI
Intermedics Orthopedics
Orthopedic · 755d
Cleared Dec 13, 1995
DEROYAL SURGICAL INSTRUMENT DRAPE
K950565 · KKX
Deroyal Industries, Inc.
General Hospital · 308d