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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161329–161352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1982
SPIROX A
K812959 · BZK
Cairco , Ltd.
Anesthesiology · 93d
Cleared Jan 22, 1982
AGGLUTEX AMPHETAMINE TEST KIT
K812986 · DJP
Hoffmann-La Roche, Inc.
Toxicology · 88d
Cleared Jan 22, 1982
DISPOSABLE ARTHROSCOPY CANNULA SET
K813000 · LXH
Clinical Technology Corp.
Orthopedic · 88d
Cleared Jan 22, 1982
SODIUM & POTASSIUM PRODUCTS
K813127 · JIX
Alko Diagnostic Corp.
Chemistry · 78d
Cleared Jan 22, 1982
BRADYCARDIA ALARM
K813174 · DRT
Douglas Scientific Products
Cardiovascular · 77d
Cleared Jan 22, 1982
REGU-VAC OXYGENATING SUCTION CATHETER
K813220
Bd Becton Dickinson Vacutainer...
Cardiovascular · 74d
Cleared Jan 22, 1982
NEOCARE BABY-CONTROLLED INCUBATOR
K813238 · FMZ
Vickers America Medical Corp.
General Hospital · 66d
Cleared Jan 22, 1982
PRE-PACK TENS
K813286 · GDY
Cunningham Woodland, Inc.
General & Plastic Surgery · 60d
Cleared Jan 22, 1982
CONPHAR LARYNGOSCOPE
K813297 · EQN
Conphar, Inc.
Ear, Nose, Throat · 60d
Cleared Jan 22, 1982
CONPHAR PALM ANEROID SPHYGMOMANOMETER
K813302 · DXQ
Conphar, Inc.
Cardiovascular · 60d
Cleared Jan 22, 1982
CONPHAR, WALL ANEROID SPHYGMOMANOMETER
K813303 · DXQ
Conphar, Inc.
Cardiovascular · 60d
Cleared Jan 22, 1982
RADIONUCLIDE DOSE CALIBRATOR
K813379 · KPT
Medi Nuclear Corp., Inc.
Radiology · 52d
Cleared Jan 22, 1982
DISPOSABLE ADULT ANES. CIRCUIT
K813382 · CAI
Intec.
Anesthesiology · 51d
Cleared Jan 22, 1982
DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM
K813394 · GCX
Cox-Uphuff Intl.
General Hospital · 49d
Cleared Jan 22, 1982
ERG-JET ELECTRODE
K813399 · HLZ
Nicolet Biomedical Instruments
Ophthalmic · 49d
Cleared Jan 22, 1982
COMFORT CUSHION DRY BURN PAD III
K813419 · NAB
American Convertors Div., American...
General & Plastic Surgery · 46d
Cleared Jan 22, 1982
LASER PHOTOCOAGULATOR ARGON MED. LASER
K813429 · HPJ
American Laser Corp.
Hematology · 45d
Cleared Jan 22, 1982
RTP-5000
K813439 · JAD
Adac Laboratories
Radiology · 45d
Cleared Jan 22, 1982
BOUNDARY SINGLE-USE DRAPES
K813450 · KKX
The Buckeye Cellulose Corp.
General Hospital · 43d
Cleared Jan 22, 1982
5B SLAVE MODULE SYRINGE PUMP
K813473 · FRN
Baxter Healthcare Corp
General Hospital · 39d
Cleared Jan 22, 1982
OMS INFUSION CANNULA ASSEMBLE
K813481 · HMX
Optical Micro Systems, Inc.
Ophthalmic · 52d
Cleared Jan 22, 1982
OMS ANTERIOR CHAMBER INFUSION NEEDLE
K813483
Optical Micro Systems, Inc.
Ophthalmic · 52d
Cleared Jan 22, 1982
BRITT KRYPTON LASERS 150K & 152K
K813492 · HQF
Britt Corp., Inc.
Ophthalmic · 42d
Cleared Jan 22, 1982
COMMAND P5
K813534 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 36d