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
97705–97728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1996
GUGLIELMI DETACHABLE COIL
K960705 · HCG
Target Therapeutics
Neurology · 90d
Cleared May 21, 1996
LRM
K960718 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 90d
Cleared May 21, 1996
DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING
K961085 · MGQ
Debusk Knitting Mills, Div. Deroyal...
General & Plastic Surgery · 63d
Cleared May 21, 1996
SOFT-55 DAILY WEAR CONTACT LENS
K961428 · LPL
Lombart Lenses, Ltd.
Ophthalmic · 36d
Cleared May 20, 1996
MODEL KM-25
K951449 · IYO
Koven Technology, Inc.
Radiology · 418d
Cleared May 20, 1996
THE CHEN MEDIUM
K954548 · LYX
Chen Ophthalmic Laboratories
Ophthalmic · 231d
Cleared May 20, 1996
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K954953 · CAZ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 203d
Cleared May 20, 1996
VICRYL PERIDONTAL MESH
K955646 · NPK
Ethicon, Inc.
Dental · 160d
Cleared May 20, 1996
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955673 · GKZ
Abbott Laboratories
Hematology · 196d
Cleared May 20, 1996
NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
K955703 · KIF
Neodental Chemical Products Co., Ltd.
Dental · 158d
Cleared May 20, 1996
BENZODIAZEPINE SERUM TOX EIA TEST
K960708 · JXM
Diagnostic Reagents, Inc.
Toxicology · 89d
Cleared May 20, 1996
ORCA
K960907 · OXO
Lunar Corp.
Radiology · 76d
Cleared May 20, 1996
CLINIX MP
K960920 · OWB
Philips Medical Systems (Cleveland),...
Radiology · 75d
Cleared May 20, 1996
SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP
K960979 · DZE
Steri-Oss, Inc.
Dental · 70d
Cleared May 20, 1996
ETEST SUBMISSION FOR IMIPENEM
K960989 · JWY
Ab Biodisk
Microbiology · 70d
Cleared May 20, 1996
ETEST SUBMISSION FOR VANCOMYCIN
K960990 · JWY
Ab Biodisk
Microbiology · 70d
Cleared May 20, 1996
285 SL
K961352 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)
K961528 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 12 ANTISERUM
K961529 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 13 ANTISERUM
K961531 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM
K961532 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM
K961533 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)
K961534 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM
K961535 · GNB
Sa Scientific, Inc.
Microbiology · 28d