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
143281–143304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1986
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
K862349 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Jul 07, 1986
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
K862350 · KLS
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Jul 07, 1986
EPICATH
K862358 · KNE
Hdc Corp.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 1986
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
K862365 · HIO
Swemed Laboratories, Inc.
Obstetrics & Gynecology · 13d
Cleared Jul 03, 1986
SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
K855232 · GWF
Neuroscience, Inc.
Neurology · 185d
Cleared Jul 03, 1986
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
K860472 · IWE
Nuclear Diagnostics, Inc.
Radiology · 147d
Cleared Jul 03, 1986
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM
K860574 · LQG
Gen-Probe, Inc.
Microbiology · 139d
Cleared Jul 03, 1986
7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER)
K861228 · ITX
General Electric Co.
Radiology · 93d
Cleared Jul 03, 1986
COMBISON R 320A
K861376 · IYO
Cone Instruments, Inc.
Radiology · 85d
Cleared Jul 03, 1986
EMPI MODEL 720 NMS, TENS
K861451 · GZJ
Empi
Neurology · 76d
Cleared Jul 03, 1986
MONO-LATEX (TM) SLIDE TEST
K862008 · KTN
Armkel, LLC
Immunology · 37d
Cleared Jul 03, 1986
MULTI-DAY ELECTRODES
K862011 · GXY
Medical Electronic Assn.
Neurology · 36d
Cleared Jul 03, 1986
CONCORD CARE TRAY
K862039
Concord Laboratories, Inc.
General & Plastic Surgery · 36d
Cleared Jul 03, 1986
MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD
K862052 · DTB
Intermedics, Inc.
Cardiovascular · 35d
Cleared Jul 03, 1986
PERENNIAL RYE ALLERGEN DISC
K862173 · DHB
Immuno Nuclear Corp.
Immunology · 24d
Cleared Jul 03, 1986
ENGLISH PLAINTAIN ALLERGEN DISC
K862264 · DHB
Immuno Nuclear Corp.
Immunology · 20d
Cleared Jul 03, 1986
AMPLIFIED ELISA IGE KIT
K862368 · DGC
Allertec, Inc.
Immunology · 9d
Cleared Jul 03, 1986
BIOTIS HAEMOPHILUS IDENTIFICATION QUAD
K862387 · JSH
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS TCBS AGAR
K862388 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS ACETAMIDE AGAR
K862389 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS BORDET GENGOU AGAR
K862390 · KZI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DESOXYCHOLATE AGAR
K862391 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS MOTILITY TEST MEDIUM
K862392 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS LITMUS MILK
K862393 · JSE
Otisville Biotech, Inc.
Microbiology · 9d