FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86641–86664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1999
ENVY GUIDING CATHETER
K990726 · DQY
Cook, Inc.
Cardiovascular · 28d
Cleared Apr 02, 1999
SOF-SUCTION FLUID EVACUATION SYSTEM
K990749 · HOZ
X-Tech Medical, LLC
Ophthalmic · 25d
Cleared Apr 02, 1999
VISION PORCELAIN
K990790 · EIH
Servo Dental USA, Inc.
Dental · 23d
Cleared Apr 01, 1999
INTERPLANT
K982696 · MUJ
Burdette Medical Systems, Inc.
Radiology · 241d
Cleared Apr 01, 1999
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
K983524 · GEX
Lares Research, Inc.
General & Plastic Surgery · 175d
Cleared Apr 01, 1999
POINT SETTER
K984355 · GCJ
Mitaka USA, Inc.
General & Plastic Surgery · 115d
Cleared Apr 01, 1999
QUICKRAY DSX 730
K990002 · MUH
Julie Alliance
Radiology · 87d
Cleared Apr 01, 1999
OPART, MODEL MRT-600
K990007 · MOS
Toshiba America Mri, Inc.
Radiology · 87d
Cleared Apr 01, 1999
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K990028 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 86d
Cleared Apr 01, 1999
ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL...
K990174 · GEX
Fisma, Inc.
General & Plastic Surgery · 72d
Cleared Apr 01, 1999
MDILOG, MODEL MDC-512
K990185 · CAF
Medtrak Technologies, Inc.
Anesthesiology · 71d
Cleared Apr 01, 1999
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
K990188 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 71d
Cleared Apr 01, 1999
CRX WORLD SHUNT
K990256 · JXG
Phoenix Biomedical Corp.
Neurology · 64d
Cleared Apr 01, 1999
OMNI-FIX, NAIL SYSTEM
K990307 · KTW
Turnkey Intergration USA, Inc.
Orthopedic · 59d
Cleared Apr 01, 1999
PERRY HUMERAL NAIL
K990322 · HSB
Pioneer Surgical Technology
Orthopedic · 58d
Cleared Apr 01, 1999
COULTER AC T DIFF 2 ANALYZER
K990352 · GKZ
Coulter Corp.
Hematology · 55d
Cleared Apr 01, 1999
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
K990951 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 10d
Cleared Apr 01, 1999
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
K990952 · GAT
United States Surgical, A Division of...
General & Plastic Surgery · 10d
Cleared Mar 31, 1999
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
K990086 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 79d
Cleared Mar 31, 1999
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
K990220 · FCG
Medi-Globe Corp.
Gastroenterology & Urology · 68d
Cleared Mar 31, 1999
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K990251 · LFM
Dade Behring, Inc.
Toxicology · 63d
Cleared Mar 31, 1999
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR...
K990264 · HQD
Metro Optics of Austin, Inc.
Ophthalmic · 63d
Cleared Mar 31, 1999
VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
K990311 · GKZ
Abx Diagnostics
Hematology · 58d
Cleared Mar 31, 1999
ENDOSHEATH
K990354 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 54d