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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117649–117672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1992
CHEMSTRIP URINE ANALYZER
K921087 · KQO
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Mar 23, 1992
CROSSLINK SYSTEM
K911663 · KWP
Synthes (Usa)
Orthopedic · 346d
Cleared Mar 23, 1992
PROSPECT(TM/CRYPTOSPORIDIUM
K912242 · MHJ
Alexon, Inc.
Microbiology · 307d
Cleared Mar 23, 1992
LM15(TM), CATALOG NUMBER - 523821
K914690 · GCJ
Edward Weck, Inc.
General & Plastic Surgery · 157d
Cleared Mar 23, 1992
SEROLISA CHLAMYDIA IGG TEST KIT
K915281 · LJC
Savyon Diagnostics , Ltd.
Microbiology · 119d
Cleared Mar 23, 1992
DIRECTIGEN MENINGITIS COMBO TEST KIT
K915330 · GTJ
Bd Becton Dickinson Vacutainer...
Microbiology · 118d
Cleared Mar 23, 1992
TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED
K915521 · DQY
Target Therapeutics
Cardiovascular · 144d
Cleared Mar 23, 1992
COATED VICRYL* II
K915835 · GAM
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Mar 23, 1992
ZEISS MULTIYAG LASER
K915840 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 90d
Cleared Mar 23, 1992
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
K915868 · KWL
Orthomet, Inc.
Orthopedic · 84d
Cleared Mar 23, 1992
OPUS RUBELLA TEST SYSTEM
K915870 · LFX
Pb Diagnostics, Inc.
Pathology · 83d
Cleared Mar 23, 1992
NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL
K920167 · HBI
Nextec Corp.
General & Plastic Surgery · 73d
Cleared Mar 23, 1992
CHEM-CHEM MULTI-ANALYTE (MODIFIED)
K920350 · JJY
Streck Laboratories, Inc.
Chemistry · 59d
Cleared Mar 23, 1992
CEFPROZIL 30MCG, SENSI DISC
K920473 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 55d
Cleared Mar 23, 1992
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505 · JHI
Eastman Kodak Company
Chemistry · 47d
Cleared Mar 23, 1992
BBL STREP GROUPING KIT
K920565 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 45d
Cleared Mar 23, 1992
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
K920576 · CGI
Eastman Kodak Company
Chemistry · 42d
Cleared Mar 23, 1992
8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET
K920694 · FPA
Baxter Healthcare Corp
General Hospital · 38d
Cleared Mar 23, 1992
STRYKER I.V. CADDY ACCESSORY DEVICE
K920704 · FPO
Stryker Medical
General Hospital · 34d
Cleared Mar 23, 1992
MP/S SINGLE WAVELENGTH MINI PHOTOMETER
K920914 · JJQ
Artel, Inc.
Chemistry · 25d
Cleared Mar 23, 1992
SYNERMED LDHH-L REAGENT KIT
K921025 · CFJ
Synermed, Inc.
Chemistry · 20d
Cleared Mar 20, 1992
MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM
K911911 · HCC
Medical Design & Manufacturing Corp.
Neurology · 325d
Cleared Mar 20, 1992
SYSTEM 3000 ELECTRONIC INSUFFLATOR
K913873 · HIF
Cabot Medical Corp.
Obstetrics & Gynecology · 204d
Cleared Mar 20, 1992
MODIFIED ASAHI PAN-SERIES HEMOFILTERS
K914020 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 193d