Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
159121–159144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1982
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
K822681 · DHN
Amico Lab, Inc.
Microbiology · 101d
Cleared Dec 13, 1982
YSI MODEL 23L LACTATE ANALYZER
K822812 · HHP
Yellow Springs Instrument Co., Inc.
Chemistry · 84d
Cleared Dec 13, 1982
UROCOMP REMOTE CONTROL 1804
K822916 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 73d
Cleared Dec 13, 1982
MINISTIM 180
K822924 · IPF
Micron Instruments, Inc.
Physical Medicine · 73d
Cleared Dec 13, 1982
THE PROGRESSIVE CHAIR
K823277 · INN
Progressive Productions , Ltd.
Physical Medicine · 40d
Cleared Dec 09, 1982
AIRWAY TEMPERATURE SENSOR
K821505 · GEI
Mon-A-Therm, Inc.
General & Plastic Surgery · 203d
Cleared Dec 09, 1982
ECHO-PULSE KM555
K821736 · GXW
Rabar, Inc.
Neurology · 178d
Cleared Dec 09, 1982
EBV IGM TEST
K822734 · JRY
Gull Laboratories, Inc.
Microbiology · 91d
Cleared Dec 09, 1982
DSL 1600
K822898 · CIA
Diagnostic Systems Laboratories, Inc.
Chemistry · 71d
Cleared Dec 09, 1982
INNOTRON FLUORIMETER SERIES ONE-10
K822942 · KHO
Innotron of Oregon, Inc.
Chemistry · 66d
Cleared Dec 09, 1982
KM-KAL L3
K823044 · JIX
Kmn Products, Inc.
Chemistry · 55d
Cleared Dec 09, 1982
DOSOMETRIC RELEASE STERILIZATION
K823058 · EFQ
Stan-Pak Ent.
General & Plastic Surgery · 52d
Cleared Dec 09, 1982
KOAGULAB 40-A AUTOMATED COAGULATION SYS
K823131 · KQG
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Dec 09, 1982
MYSTIK AUTOCLAVE TAPE
K823208 · JOJ
Mystik Corp.
General Hospital · 42d
Cleared Dec 09, 1982
NON-REUSABLE UNIVERSAL NEBULIZER FILTE
K823257 · CAH
Ohio Medical Products
General Hospital · 38d
Cleared Dec 09, 1982
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 37d
Cleared Dec 09, 1982
RESPIRATORY CIRCUIT ADAPTOR
K823287 · BZO
Thoratec Laboratories Corp.
Anesthesiology · 35d
Cleared Dec 09, 1982
CHOLESTEROL CHOD-PAP TEST
K823302 · CHH
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Dec 09, 1982
CENTRAL VENOUS CATHETER
K823351 · FOZ
Plasmedics, Inc.
General Hospital · 30d
Cleared Dec 09, 1982
OXYGEN MONITOR IL 408
K823374 · CCL
Instrumentation Laboratory CO
Anesthesiology · 27d
Cleared Dec 09, 1982
HEARING AID HB-33 RIONET
K823383 · ESD
Kindel & Anderson
Ear, Nose, Throat · 27d
Cleared Dec 09, 1982
HEARING AID HB-72 RIONET
K823384 · ESD
Kindel & Anderson
Ear, Nose, Throat · 27d
Cleared Dec 09, 1982
PRISMA C-REACTIVE PROTEIN CONTROLS
K823415 · DCK
Syva Co.
Chemistry · 24d
Cleared Dec 09, 1982
PRISMA C-REACTIVE PROTEIN ASSAY
K823416 · DCK
Syva Co.
Immunology · 24d