FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94369–94392 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1997
DISPENS-O-DISC SPARFLOXACIN
K971211 · JTN
Difco Laboratories, Inc.
Microbiology · 18d
Cleared Apr 11, 1997
VENISECT LASER LANCET
K955653 · GEX
Venisect, Inc.
General & Plastic Surgery · 486d
Cleared Apr 11, 1997
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
K961924 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 329d
Cleared Apr 11, 1997
LEIBINGER IMF SCREW
K963030 · DZE
Howmedica Leibinger, Inc.
Dental · 249d
Cleared Apr 11, 1997
DERMA 20 LASER SYSTEM
K964253 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 169d
Cleared Apr 11, 1997
SMF STAINLESS STEEL BONE SCREWS
K964261 · DZL
Synthes (Usa)
Dental · 168d
Cleared Apr 11, 1997
HYBRID RESIN COMPOSITE
K964867 · KLE
Parkell, Inc.
Dental · 127d
Cleared Apr 11, 1997
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · ELC
Dentsply Intl.
Dental · 87d
Cleared Apr 11, 1997
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
K970128 · KPS
Park Medical Systems, Inc.
Radiology · 87d
Cleared Apr 11, 1997
OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
K970184 · GEI
Olympus America, Inc.
General & Plastic Surgery · 84d
Cleared Apr 11, 1997
PATIENT RESTRAINT
K970272 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970273 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970274 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970275 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
MICROVASIVE GOLD PROBE
K970278 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Apr 11, 1997
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
K970453 · MGQ
B.Braun Medical, Inc.
General & Plastic Surgery · 79d
Cleared Apr 11, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K970563 · FCG
Olympus America, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 11, 1997
LEE PLATE
K970911 · JEY
Howmedica Leibinger, Inc.
Dental · 30d
Cleared Apr 10, 1997
CARDIO TEAM II
K962937 · DXH
Vision Electronics
Cardiovascular · 255d
Cleared Apr 10, 1997
MYELOPEROXIDASE ELISA TEST SYSTEM
K964446 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
PROTEINASE-3 IGG ELISA TEST SYSTEM
K964448 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
ANCA SCREEN ELISA TEST SYSTEM
K964449 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
K970185 · KKX
Contour Fabricators, Inc.
General Hospital · 83d
Cleared Apr 10, 1997
TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
K970370 · FMI
Tsk Laboratory, Japan
General Hospital · 69d