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
167569–167592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1980
DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
K800894 · JDI
Depuy, Inc.
Orthopedic · 14d
Cleared May 02, 1980
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)
K800898 · JDS
Dow Corning Corp. Healthcare...
Orthopedic · 14d
Cleared May 02, 1980
TRU-COLD THERAPY PAK
K800917 · IME
Tru-Eze Mfg. Co., Inc.
Physical Medicine · 10d
Cleared May 02, 1980
PERSONAL SITZ BATH KIT
K800958 · KTC
The Healthcare Group Laboratories, Inc.
Physical Medicine · 9d
Cleared May 02, 1980
AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)
K800994 · EJS
Howmedica Corp.
Dental · 7d
Cleared May 02, 1980
FLOW MED 160
K801004 · FPA
D.R.O. Medical, Inc.
General Hospital · 7d
Cleared Apr 29, 1980
PHADEBACT STREP D TEST
K800159 · GTZ
Pharmacia, Inc.
Microbiology · 96d
Cleared Apr 29, 1980
STERILE SPONGE BOWLS
K800440 · FNY
Premium Plastics, Inc.
General Hospital · 61d
Cleared Apr 29, 1980
3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM
K800487 · JDI
3M Company
Orthopedic · 56d
Cleared Apr 29, 1980
MX820-5 PRESSURE INFUSOR 500CC MX820-10
K800560 · KZD
Medex, Inc.
General Hospital · 48d
Cleared Apr 29, 1980
RADIOEAR MODEL RM-L & RM-C HEARING AID
K800567 · ESD
Radioear Corp.
Ear, Nose, Throat · 47d
Cleared Apr 29, 1980
EXTENSION LINE
K800622 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 42d
Cleared Apr 29, 1980
AUTO-FIELD D AUTOMATED VISUAL DETECTOR
K800722 · HPT
Cavitron Corp.
Ophthalmic · 28d
Cleared Apr 29, 1980
BELTLESS MAXI, MINI & SUPER MAXI PADS
K800747 · HHD
Dafoe & Dafoe, Inc.
Obstetrics & Gynecology · 25d
Cleared Apr 29, 1980
NICKERSON'S MED. SELECTIVE CULTURE MEDIU
K800754 · JSJ
Ortho Pharmaceutical Corp.
Microbiology · 25d
Cleared Apr 29, 1980
DRAGER ORMC
K800764 · BZR
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared Apr 29, 1980
DIGITAL ELECTRONIC B.P. MONITOR 2155
K800778 · DXN
Sears, Roebuck & Co.
Cardiovascular · 21d
Cleared Apr 29, 1980
MINUET MASKER
K800784 · KLW
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Apr 29, 1980
FAST HEMOGLOBIN CONTROL-LYOPHILIZED
K800794 · LCP
Isolab, Inc.
Chemistry · 20d
Cleared Apr 29, 1980
QUICK FILL
K800823 · DXT
Medrad, Inc.
Cardiovascular · 15d
Cleared Apr 29, 1980
PREMIER ABSORBENT POINTS
K800827 · EKN
Premier Dental Products Co.
Dental · 15d
Cleared Apr 29, 1980
MYERSON'S SPECIAL CROWN & BRIDGE RESIN
K800828 · EBG
Myerson Tooth Corp.
Dental · 15d
Cleared Apr 29, 1980
A,SA2 LYOPHILIZED HEMO CONTROL
K800853 · JBD
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
A,A2 LYOPHILIZED HEMO CONTROL
K800854 · JBD
Helena Laboratories
Hematology · 14d