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
169753–169776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1979
PULSE GENERATOR, MODEL 171
K782161 · DXY
Telectronics, Inc.
Cardiovascular · 215d
Cleared Jul 24, 1979
BATTERY CHARGER, 171 PACEMAKER
K782162 · DXY
Telectronics, Inc.
Radiology · 215d
Cleared Jul 24, 1979
RIA, INSULIN, DOUBLE ANTIBODY
K790630 · CFP
Endocrine-Metabolic Center
Chemistry · 119d
Cleared Jul 24, 1979
CORNING PARAPROTEIN SCREENING
K790667 · CFF
Corning Medical & Scientific
Immunology · 109d
Cleared Jul 24, 1979
MODEL 4000, SPECTROPHOTOMETER
K790795 · JXR
The Perkin-Elmer Corp.
Toxicology · 91d
Cleared Jul 24, 1979
DUALUME LARYNGEAL EXAMINATION TELESCOPE
K790845 · ENZ
National Medical Technology
Ear, Nose, Throat · 81d
Cleared Jul 24, 1979
STRESS/EMERGENCY EELCTRODE
K790883
Hayes Products, Inc.
Neurology · 76d
Cleared Jul 24, 1979
MISTY NEBULIZER
K790892 · CAF
Airlife, Inc.
Anesthesiology · 78d
Cleared Jul 24, 1979
ANTI-DNASE B REAGENT SYSTEM
K790997 · GTR
Calbiochem-Behring Corp.
Microbiology · 56d
Cleared Jul 24, 1979
PROTHROMBIN REFERENCE PLASMA (HUMAN)
K791022 · GJS
Pacific Hemostasis
Hematology · 55d
Cleared Jul 24, 1979
PROGESTERONE RADIOIMMUNOASSAY KIT
K791051 · JLS
Cis Radiopharmaceuticals, Inc.
Chemistry · 48d
Cleared Jul 24, 1979
BECKMAN ELECTROPHORESIS OVEN/INCUBATOR
K791077 · JRJ
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Jul 24, 1979
PLUS CHEM S.C.E. REAGENT
K791080 · CIT
Smithkline Diagnostics, Inc.
Chemistry · 42d
Cleared Jul 24, 1979
3M ORTHOPEDIC CASTING TAPE
K791094 · ITG
3M Company
Physical Medicine · 42d
Cleared Jul 24, 1979
B & L OPHTHALMIC INSTRUMENT STAND
K791104 · HMF
Bausch & Lomb, Inc.
Ophthalmic · 41d
Cleared Jul 24, 1979
B & L OPHTHALMIC CHAIR
K791105 · HMF
Bausch & Lomb, Inc.
Ophthalmic · 41d
Cleared Jul 24, 1979
SINGLE USE MONOPOLAR HAND CONTROL PENCIL
K791137 · GEI
Davol, Inc.
General & Plastic Surgery · 36d
Cleared Jul 24, 1979
5880 SERIES OF GAS CHROMATOGRAPHS
K791138 · KZQ
Hewlett-Packard Co.
Toxicology · 36d
Cleared Jul 24, 1979
PORTABLE ASPIRATOR
K791210 · JCX
Sam Say Assoc.
General & Plastic Surgery · 22d
Cleared Jul 24, 1979
BRIOX MODEL 2000-CQ QUIET COMPRESSOR
K791238 · JCX
Briox Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Jul 24, 1979
BRIOX MODEL 2000-A ASPIRATOR UNIT
K791239 · JCX
Briox Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Jul 24, 1979
BRIOX MODEL 2000-C COMPRESSOR UNIT
K791240 · JCX
Briox Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Jul 24, 1979
BRIOX MODEL 2000-CA COMPRESSOR UNIT
K791241 · JCX
Briox Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Jul 24, 1979
CONPHAR NASAL OXYGEN CANNULA-STERILE
K791247 · CAT
Conphar, Inc.
Anesthesiology · 18d