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
92065–92088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1997
SPIFE
K972274 · CEF
Helena Laboratories
Chemistry · 131d
Cleared Oct 27, 1997
RAPID FIRE HAIR IMPLANTER CAROUSEL
K972918 · GAH
Apex Medical Products, LLC
General & Plastic Surgery · 81d
Cleared Oct 27, 1997
SUPER SILIPLUGS EAR PLUGS
K972923 · EWD
Interview Medical Technology Corp.
Ear, Nose, Throat · 80d
Cleared Oct 27, 1997
VOX/BASE FOR WINDOWS
K972933 · LLZ
J-Mac System, Inc.
Radiology · 80d
Cleared Oct 27, 1997
MODEL C-1 HEARING AID
K973043 · ESD
Better Hearing, Inc.
Ear, Nose, Throat · 73d
Cleared Oct 27, 1997
COMPRESSION CERCLAGE GUNDOLF CCG-GF
K973098 · JDQ
Plus Orthopedics
Orthopedic · 69d
Cleared Oct 27, 1997
MIDAS TOUCH ELECTROSURGICAL ELECTRODE
K973234 · GEI
Iti Medical Technologies, Inc.
General & Plastic Surgery · 60d
Cleared Oct 27, 1997
TBD* ONE-STEP OVULATION PREDICTOR TEST
K973310 · CEP
Armkel, LLC
Chemistry · 54d
Cleared Oct 27, 1997
BRAND NAME *1-STEP PREGNANCY
K973352 · LCX
Armkel, LLC
Chemistry · 52d
Cleared Oct 27, 1997
OPUS HLH CONTROLS
K973832 · JJX
Behring Diagnostics, Inc.
Toxicology · 20d
Cleared Oct 24, 1997
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
K964398 · MGP
Polymedica Industries, Inc.
General & Plastic Surgery · 354d
Cleared Oct 24, 1997
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
K970595 · FEN
Circon Video
Gastroenterology & Urology · 248d
Cleared Oct 24, 1997
SMC ACETABULAR COMPONENT
K971018 · LPH
Signal Medical Corp.
Orthopedic · 218d
Cleared Oct 24, 1997
EVI SUTURED-CLIP APPLIER
K971588 · FZP
Elective Vascular Intervention Inc....
General & Plastic Surgery · 176d
Cleared Oct 24, 1997
AUTO SUTURE BONE WAX
K971680 · MTJ
United States Surgical, A Division of...
General & Plastic Surgery · 170d
Cleared Oct 24, 1997
DERMASCAN SURGICAL LASER SCANNER
K972028 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 144d
Cleared Oct 24, 1997
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND...
K972471 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 115d
Cleared Oct 24, 1997
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
K972621 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 102d
Cleared Oct 24, 1997
HANSATOME MICROKERATOME
K972808 · HNO
Chiron Vision Corp.
Ophthalmic · 88d
Cleared Oct 24, 1997
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
K972867 · ICX
Rocket Medical Plc
Pathology · 81d
Cleared Oct 24, 1997
TRI TALON RETRIEVAL FORCEPS
K973071 · OCZ
Medical Engineering Laboratory, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 24, 1997
TOTAL PERFORMANCE SYSTEM SHAVER
K973195 · HRX
Stryker Endoscopy
Orthopedic · 59d
Cleared Oct 24, 1997
HANAULUX BLUE 75 AND HANAULUX BLUE 120
K973466 · FSY
Heraeus Med GmbH
General & Plastic Surgery · 70d
Cleared Oct 24, 1997
DURALASTIC ANATOMICAL MALAR IMPLANT
K973574 · LZK
Hanson Medical, Inc.
General & Plastic Surgery · 35d