FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123145–123168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1991
RETIC-CHEX
K905524 · JPK
Streck Laboratories, Inc.
Hematology · 72d
Cleared Feb 20, 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K905639 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 65d
Cleared Feb 20, 1991
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · JEY
Walter Lorenz Surgical, Inc.
Dental · 47d
Cleared Feb 20, 1991
PHILIPS BV-29 IMAGING SYSTEM
K910115 · OXO
Philips Medical Systems, Inc.
Radiology · 41d
Cleared Feb 19, 1991
CORE-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900180 · DZE
Core-Vent Corp.
Dental · 399d
Cleared Feb 19, 1991
ITC BUNJI COIL
K900723 · HCG
Interventional Therapeutics Corp.
Neurology · 369d
Cleared Feb 19, 1991
LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM
K903131 · GEX
Lasermatic, Inc.
General & Plastic Surgery · 217d
Cleared Feb 19, 1991
SANDBOX I, SANDBOX II, SANDBOX JR.
K903321 · IRT
Sandbox Ent.
Physical Medicine · 209d
Cleared Feb 19, 1991
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
K903771 · DXN
Hewlett-Packard Co.
Cardiovascular · 183d
Cleared Feb 19, 1991
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
K904000 · HIS
Armkel, LLC
Obstetrics & Gynecology · 174d
Cleared Feb 19, 1991
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY
K904169 · IZO
Varian Canada, Inc.
Radiology · 161d
Cleared Feb 19, 1991
SINGLE USE LAPARSCOPIC ELECTRODE
K904240 · HFG
Aspen Labs
Obstetrics & Gynecology · 159d
Cleared Feb 19, 1991
AUTODERM SCANNER CONTROL CONSOLE
K904266 · GEX
Charles I. Rose & Co., Inc.
General & Plastic Surgery · 154d
Cleared Feb 19, 1991
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST
K904691 · HFM
Air-Shields Vickers, Inc.
Obstetrics & Gynecology · 126d
Cleared Feb 19, 1991
ENDOCOAGULATOR KRS568(TM) LASER
K904700 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 126d
Cleared Feb 19, 1991
IMMITTANCE METER, MODEL AE-105D/S
K905212 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 91d
Cleared Feb 19, 1991
NEW USCI 7F PTCA GUIDING CATHETER
K905249 · DQY
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Feb 19, 1991
CONDOM (RUBBER) CONTRACEPTIVE
K905279 · HIS
Aladan Corp.
Obstetrics & Gynecology · 88d
Cleared Feb 19, 1991
CATALOG NUMBER 2609 LEG PLATE
K905295 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 84d
Cleared Feb 19, 1991
ALGODERM ALGINATE WOUND DRESSING
K905314 · FRO
Les Laboratorires Brothier, S.A.
General & Plastic Surgery · 83d
Cleared Feb 19, 1991
THE DART
K905549 · HIF
Dexide, Inc.
Obstetrics & Gynecology · 70d
Cleared Feb 19, 1991
SILICONE COATED GUIDEWIRES
K905581 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 69d
Cleared Feb 19, 1991
FST CATH-UD CATHETER
K905641 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 19, 1991
RICHARD-ALLAN CLAMP COVERS
K905682 · FSM
Richard-Allan Medical
General & Plastic Surgery · 62d