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
171409–171432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1978
EMIT ANTIEPILEPTIC DRUG CALIBRATORS
K780467 · JIS
Syva Co.
Toxicology · 33d
Cleared Apr 24, 1978
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT
K780475 · DON
Burroughs Wellcome Co.
Toxicology · 31d
Cleared Apr 24, 1978
DISC-PAK ROTATOR
K780544 · GLE
Techhnilab Instruments, Inc.
Hematology · 21d
Cleared Apr 24, 1978
SPECT RIM (LISS)
K780556 · KSG
Bd Becton Dickinson Vacutainer...
Hematology · 19d
Cleared Apr 21, 1978
THERAPEUTIC APPARATUS, DIERKER TYPE
K770534 · KDH
Well Being Ent.
Gastroenterology & Urology · 396d
Cleared Apr 21, 1978
RATE PROGRAMMER MODEL 520
K780175 · KRG
Intermedics, Inc.
Cardiovascular · 77d
Cleared Apr 21, 1978
BLOOD FLOWMETER SYSTEM
K780302 · DPW
Medtronic Vascular
Cardiovascular · 58d
Cleared Apr 21, 1978
PANTRIDGE MK III DEFIBRILLATOR/MONITOR
K780416 · LDD
Ipco Corp.
Cardiovascular · 38d
Cleared Apr 21, 1978
ACTIVE-LIFE
K780454 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 21, 1978
SNAP-FIT
K780511 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 22d
Cleared Apr 21, 1978
PERCUTANEOUS SHEATH INTRODUCER KIT
K780532 · DYB
Arrow Intl., Inc.
Cardiovascular · 17d
Cleared Apr 21, 1978
ELECTRIC RESPONSE AUDIOMETER
K780540 · GWJ
Life-Tech Instruments, Inc.
Neurology · 18d
Cleared Apr 21, 1978
DENTAL AMALGAMATOR
K780560 · EFD
L.D. Caulk Co.
Dental · 16d
Cleared Apr 21, 1978
HEALTH SEAT SYSTEM
K780566 · DXN
G & W Applied Science Laboratories
Cardiovascular · 15d
Cleared Apr 21, 1978
COLD PACK
K780603 · IMD
Abco Dealers, Inc.
Physical Medicine · 11d
Cleared Apr 21, 1978
DENTAL ROTARY CARBIDE BURS 76EJL
K780641 · EJL
Teledyne Densco
Dental · 4d
Cleared Apr 19, 1978
IMMUNOZYME E. HISTOLYTICA ANTIGENS
K780114
Millipore Corp.
Microbiology · 86d
Cleared Apr 19, 1978
HDL REAGENT SET FOR LIPOPROTEINS
K780389 · CHH
Worthington Biochemical Corp.
Chemistry · 40d
Cleared Apr 19, 1978
NERVTRON-RX
K780444 · GZJ
Medix Corp.
Neurology · 30d
Cleared Apr 19, 1978
TRANSPORTABLE OXYGEN PURITY ANALYZER
K780448 · CCL
Taylor Instrument Analytics Co.
Anesthesiology · 30d
Cleared Apr 19, 1978
INFANT INCUBATOR
K780472 · FMZ
Air-Shields, Inc.
General Hospital · 26d
Cleared Apr 19, 1978
PREMIER CARVERS, STYLE #21C & 21D
K780528 · EKH
Premier Dental Products Co.
Dental · 16d
Cleared Apr 19, 1978
AUDIO MONITOR-MODEL 8309
K780538 · GWK
Life-Tech Instruments, Inc.
Neurology · 16d
Cleared Apr 19, 1978
NON-STICK PADS
K780549 · NAB
National Patent Development Corp.
General & Plastic Surgery · 14d