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
136873–136896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1988
CELLECT LABTRAK SOFTWARE
K874320 · GKL
Instrumentation Laboratory CO
Hematology · 98d
Cleared Jan 27, 1988
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
K874354 · ETY
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 96d
Cleared Jan 27, 1988
DONALDSON NATURAL EYEPATCH 'PATIENT PAK'
K874411 · HMP
Keeler Instruments, Inc.
General & Plastic Surgery · 91d
Cleared Jan 27, 1988
DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC
K874447 · DRO
Medac, Inc.
Cardiovascular · 91d
Cleared Jan 27, 1988
MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM
K874512 · FYD
Stackhouse Assoc.
General Hospital · 86d
Cleared Jan 27, 1988
URETHRAL DILATOR ENDOSCOPE
K874530 · KOB
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 85d
Cleared Jan 27, 1988
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
K874607 · LKN
Organon Teknika Corp.
Gastroenterology & Urology · 79d
Cleared Jan 27, 1988
STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON
K874644 · FLE
Pharmetics, Inc.
General Hospital · 75d
Cleared Jan 27, 1988
MMG CATHETER PLUG W/DRAINAGE TUBE COVER
K874682 · KOD
Medical Marketing Group
Gastroenterology & Urology · 75d
Cleared Jan 27, 1988
DENTAL HAND INSTRUMENTS
K874964 · EKJ
Solway, Inc.
Dental · 56d
Cleared Jan 27, 1988
TORQUE HEX WRENCH
K875147 · DTF
Cardiac Pacemakers, Inc.
Cardiovascular · 43d
Cleared Jan 27, 1988
ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
K875162 · HHT
Ortho Diagnostic Systems, Inc.
Obstetrics & Gynecology · 42d
Cleared Jan 27, 1988
BITEK(TM) BLOOD CULTURE SYSTEM
K875259 · JSG
Definitive Diagnostics, Inc.
Microbiology · 36d
Cleared Jan 27, 1988
WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
K875275 · JTQ
Sterling Drug, Inc.
Microbiology · 34d
Cleared Jan 27, 1988
MODEL UCA / SPEC SYSTEM UCA
K875305 · FZH
Spec Systems, Inc.
General & Plastic Surgery · 29d
Cleared Jan 27, 1988
MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE
K875321 · IOQ
Kinetic Concepts, Inc.
Physical Medicine · 29d
Cleared Jan 27, 1988
BREWER GEL FOR ANAEROBES
K875362 · KZJ
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 27d
Cleared Jan 27, 1988
GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS
K880083 · FJI
Gambro, Inc.
Gastroenterology & Urology · 15d
Cleared Jan 26, 1988
OPACITY LENSMETER 701
K874355 · HKI
Intraoptics, Inc.
Ophthalmic · 95d
Cleared Jan 26, 1988
OPTI-FIX COLLARED FEMORAL COMPONENTS
K874868 · JDG
Richards Medical Co., Inc.
Orthopedic · 60d
Cleared Jan 26, 1988
GOOD LOOKS DAZZLERS
K875067 · HQY
Mel Appel
Ophthalmic · 48d
Cleared Jan 22, 1988
WATER-JEL(R) BURN DRESSING
K864841 · FRO
Trilling Resources, Ltd.
General & Plastic Surgery · 409d
Cleared Jan 22, 1988
LSP AUTOMATIC VENTILATOR, MODEL 456
K870424 · BTL
Life Support Products, Inc.
Anesthesiology · 353d
Cleared Jan 22, 1988
MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
K871421 · IPF
Futuremed Div. of Future Impex Corp.
Physical Medicine · 288d