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
130705–130728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1989
HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
K891610 · HOD
Keeler Instruments, Inc.
Ophthalmic · 77d
Cleared Jun 05, 1989
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
K891905 · DTB
Pacesetter Systems
Cardiovascular · 70d
Cleared Jun 05, 1989
BARD(R) TIP DEFLECTING ELECTRODE CATHETER
K891908 · DRF
C.R. Bard, Inc.
Cardiovascular · 70d
Cleared Jun 05, 1989
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52
K891998 · NAD
Elwyn Industries
General & Plastic Surgery · 69d
Cleared Jun 05, 1989
LIFEPAK 250 DEFIBRILLATOR/MONITOR
K892065 · MKJ
Physio-Control Corp.
Cardiovascular · 67d
Cleared Jun 05, 1989
MT9000 CHART RECORDER
K892067 · DSH
Astro-Med, Inc.
Cardiovascular · 67d
Cleared Jun 05, 1989
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K892360 · FRO
Pfizer, Inc.
General & Plastic Surgery · 60d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-QUANTITATIVE
K892444 · DHR
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445 · DHR
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 05, 1989
VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
K893170 · HJM
Keeler Instruments, Inc.
Ophthalmic · 41d
Cleared Jun 05, 1989
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172 · HLI
Keeler Instruments, Inc.
Ophthalmic · 41d
Cleared Jun 05, 1989
VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)
K893173 · HLI
Keeler Instruments, Inc.
Ophthalmic · 41d
Cleared Jun 05, 1989
MODEL SE-5 EPILATOR
K893389 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 35d
Cleared Jun 02, 1989
KIRSCHNER SPINAL FIXATOR KMS-1
K884690 · KWP
Kirschner Medical Corp.
Orthopedic · 205d
Cleared Jun 02, 1989
GERM TUBE SOLUTION
K884720 · JXC
Remel Co.
Microbiology · 204d
Cleared Jun 02, 1989
HOUVA II UVB
K885026 · FTC
National Biological Corp.
General & Plastic Surgery · 179d
Cleared Jun 02, 1989
HOUVA II UVA/UVB
K885029 · FTC
National Biological Corp.
General & Plastic Surgery · 179d
Cleared Jun 02, 1989
PEGASUS
K885060 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 177d
Cleared Jun 02, 1989
ENTAINER(TM) ENTERAL FEEDING CONTAINER
K890430 · KNT
Entech, Inc.
Gastroenterology & Urology · 127d
Cleared Jun 02, 1989
RAPIDEC COLI
K890626 · JSS
Dms Products, Inc.
Microbiology · 115d
Cleared Jun 02, 1989
DUAL GRAPH (TM) RECORDER-MONITOR
K890711 · DSF
Somatics, Inc.
Cardiovascular · 109d
Cleared Jun 02, 1989
CMV ELISA TEST SYSTEM
K891081 · LFZ
Zeus Scientific, Inc.
Microbiology · 93d
Cleared Jun 02, 1989
DENTAL EQUIPMENT PROTECTION DEVICES
K891216 · EAZ
Pro-Safe Professional Linens, Inc.
Dental · 87d
Cleared Jun 02, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891244 · LYY
Ganda Yakin Sdn Bhd
General Hospital · 86d