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
145633–145656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1985
SARATOGA SCT HEATED HUMIDIFICATION SYSTEM
K854363 · BTT
Saratoga Medical Instrumentation, Inc.
Anesthesiology · 63d
Cleared Dec 30, 1985
EKG 501 A
K840569 · DPS
Bosch Hearing Instruments, Inc.
Cardiovascular · 691d
Cleared Dec 30, 1985
EKG 503A
K840571 · DPS
Bosch Hearing Instruments, Inc.
Cardiovascular · 691d
Cleared Dec 30, 1985
PERI-GUARD PERICARDIAL PATCH
K842066 · DXZ
Genetic Laboratories, Inc.
Cardiovascular · 616d
Cleared Dec 30, 1985
VIRATEK SMALL PARTICLE AEROSOL GENERAT
K843717
Viratek, Inc.
Cardiovascular · 465d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165
K852457 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145
K852458 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175
K852459 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115
K852653 · DXN
Healthteam
Cardiovascular · 203d
Cleared Dec 30, 1985
QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES
K853217 · IYO
Quantum Medical Systems, Inc.
Radiology · 151d
Cleared Dec 30, 1985
OSM3 HEMOXIMETER
K853990 · JKS
Radiometer America, Inc.
Chemistry · 94d
Cleared Dec 30, 1985
THE NEW MOBILE TIP MCINTYRE CANNULA
K854401 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 60d
Cleared Dec 30, 1985
THE NEW MCINTYRE I.A. HANDPIECE
K854402 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 60d
Cleared Dec 30, 1985
KEELER-COMPACT CRYO SYSTEM
K854411 · HQA
Keeler Instruments, Inc.
Ophthalmic · 59d
Cleared Dec 30, 1985
SERIES 25 SLIMLINE CRYO PROBES
K854422 · HQA
Keeler Instruments, Inc.
Ophthalmic · 56d
Cleared Dec 30, 1985
RAMP URINE HCG ASSAY
K854611 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 42d
Cleared Dec 30, 1985
DART CK-MB REAGENT SYSTEM
K854708 · JHS
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Dec 30, 1985
LECTROSTILL DISTILLED WATER U.S.P.
K854764
Electrified Companies, Inc.
Ophthalmic · 33d
Cleared Dec 27, 1985
EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS
K852178 · CAC
American Omni Medical, Inc.
Anesthesiology · 221d
Cleared Dec 27, 1985
SATALEC SERVOTOME
K852522 · EKZ
Spelna, Inc.
Dental · 196d
Cleared Dec 27, 1985
MODEL M HEARING AID
K852656 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 186d
Cleared Dec 27, 1985
SPECULITE DISPOSABLE VAGINAL LIGHT
K853257 · HIC
Trylon Associates, Ltd.
Obstetrics & Gynecology · 147d
Cleared Dec 27, 1985
VICON (MODIFICATION)
K853804 · IKN
Oxford Metrics, Inc.
Neurology · 107d
Cleared Dec 27, 1985
P.M. HIP-FEMORAL PROSTHESIS
K853916 · JDI
Advanced Biosearch Assn.
Orthopedic · 95d