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
170545–170568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1978
MINI-KEM
K781576 · JJQ
Coulter Electronics, Inc.
Toxicology · 18d
Cleared Oct 03, 1978
PORTABLE X-RAY UNIT
K781590 · IZL
General X-Ray, Inc.
Radiology · 15d
Cleared Oct 03, 1978
MEPA-1 BLOOD ANALYZER
K781606 · JJF
Medico Electronic, Inc.
Hematology · 15d
Cleared Oct 03, 1978
SIREMAT
K781613 · KPR
Siemens Corp.
Radiology · 14d
Cleared Oct 03, 1978
MOTOR RISER TOLIT LIFT
K781614 · ILS
Motor Riser Chairs , Ltd.
Physical Medicine · 22d
Cleared Oct 03, 1978
VISUALAX
K781634 · HCC
Farrall Instruments, Inc.
Neurology · 11d
Cleared Oct 03, 1978
CHLORIDE TEST SET, CAT.# 0210
K781635 · CHJ
Stanbio Laboratory
Toxicology · 11d
Cleared Oct 03, 1978
ACID FAST KIT
K781643 · JTS
Bioscientific
Pathology · 8d
Cleared Oct 03, 1978
ANTIBIOTIC NEPHELOMETER
K781644 · JQX
Biovation, Inc.
Microbiology · 8d
Cleared Oct 02, 1978
LIQUID CRYSTAL THERMOGRAPHIC SYSTEM
K780478
Thermal Imagery, Inc.
General & Plastic Surgery · 192d
Cleared Oct 02, 1978
BIO-PRO UNIT
K781303 · FKR
Bd Becton Dickinson Vacutainer...
Chemistry · 67d
Cleared Oct 02, 1978
MODEL LS-80 ADULT VENTILATION MONITOR
K781515 · BZQ
Bourns Medical Systems, Inc.
Anesthesiology · 32d
Cleared Sep 29, 1978
BRUSH, APPLICATOR
K781098 · KXR
3M Company
Dental · 88d
Cleared Sep 28, 1978
SOFT SILICONE ELASTOMER SPONGE EXPLANT
K780987 · HOZ
Medical Instrument Research Assoc., Inc.
Ophthalmic · 106d
Cleared Sep 27, 1978
PACEMAKER, MODEL 225 & 227
K772226 · DXY
Intermedics, Inc.
Cardiovascular · 295d
Cleared Sep 27, 1978
GENERATOR, PULSE, MODEL 160B
K780940 · DXY
Telectronics, Inc.
Cardiovascular · 111d
Cleared Sep 27, 1978
AIR BUBBLE DETECTOR
K781021
3M Health Care, Sarns
Cardiovascular · 100d
Cleared Sep 27, 1978
PULMO-SONIC
K781073 · CCQ
The Devilbiss Co.
Anesthesiology · 93d
Cleared Sep 27, 1978
EMIT MCA PROGRAM TAPE
K781081 · JQP
Instrumentation Laboratory CO
Toxicology · 92d
Cleared Sep 27, 1978
SPECTRASCAN
K781103 · DAT
Medishield, Inc.
Radiology · 86d
Cleared Sep 27, 1978
TONOMETER, DIGITON
K781105 · HKY
Ical, Inc.
Ophthalmic · 86d
Cleared Sep 27, 1978
IPPB ASSEMBLY W/NEBULIZER
K781232 · NHJ
Rtec
Anesthesiology · 68d
Cleared Sep 27, 1978
STIMULATOR, NERVE, TRANSCUTANEOUS
K781277 · GZJ
Psitron
Neurology · 64d
Cleared Sep 27, 1978
PULSED AND CONTINUOUS SHORTWAVE APPAR.
K781316 · IMJ
General Theraphysical, Inc.
Physical Medicine · 58d