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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101137–101160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1995
VULCAN
K953594 · EJH
Cmp Industries, LLC
Dental · 36d
Cleared Sep 01, 1995
MICRO-ARTHROSCOPE
K930084 · HRX
Medical Devices, Inc.
Orthopedic · 967d
Cleared Sep 01, 1995
WALLACE IV CANNULA
K932946 · FOZ
Smiths Industries Medical Systems, Inc.
General Hospital · 806d
Cleared Sep 01, 1995
WALLACE Y-CAN
K932947 · FOZ
Smiths Industries Medical Systems, Inc.
General Hospital · 806d
Cleared Sep 01, 1995
DYNATRON 850
K941461 · LIH
Dynatronics Research Corp.
Neurology · 526d
Cleared Sep 01, 1995
DYNATRON 550
K941577 · LIH
Dynatronics Corp.
Neurology · 519d
Cleared Sep 01, 1995
BIOINTEGRATOR, BIOINTEGRATOR PLUS
K942769 · HCC
Bio Research Institute
Neurology · 445d
Cleared Sep 01, 1995
STRYKER PRESSURE SENSING CANNULA
K944593 · HRX
Stryker Endoscopy
Orthopedic · 347d
Cleared Sep 01, 1995
LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE
K946033 · HAW
Leibinger GmbH
Neurology · 266d
Cleared Sep 01, 1995
ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH...
K950865 · MNH
Smith & Nephew Richards, Inc.
Orthopedic · 186d
Cleared Sep 01, 1995
HARMAC EXTENSION INFUSION SET
K950895 · FPA
Harmac Medical Products, Inc.
General Hospital · 186d
Cleared Sep 01, 1995
STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM
K951267 · HRX
Stryker Endoscopy
Orthopedic · 164d
Cleared Sep 01, 1995
CASCASE 480 SNSLYZER
K951497 · JPA
Helena Laboratories
Hematology · 182d
Cleared Sep 01, 1995
DYNASORB
K951561 · KMF
Dermarx Corp.
General & Plastic Surgery · 149d
Cleared Sep 01, 1995
REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE
K951908 · KGO
Regent Hospital Products
General Hospital · 130d
Cleared Sep 01, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K951932 · MEH
Osteonics Corp.
Orthopedic · 129d
Cleared Sep 01, 1995
TENDER TEMP
K951939 · FLL
Investech, Ltd.
General Hospital · 129d
Cleared Sep 01, 1995
IMAGYN ENDOSCOPE
K951996 · GCJ
Imagyn Medical, Inc.
General & Plastic Surgery · 126d
Cleared Sep 01, 1995
BACK MASSAGER
K952043 · LYG
Eight Corners, Inc.
Physical Medicine · 123d
Cleared Sep 01, 1995
SF-CHECK
K952245 · JPK
Streck Laboratories, Inc.
Hematology · 112d
Cleared Sep 01, 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
K952364 · DXY
Ela Medical, Inc.
Cardiovascular · 123d
Cleared Sep 01, 1995
GAMP & ASSOCIATES DISPOSABLE BARE END FIBER
K952580 · MPA
Gamp & Assoc.
Ophthalmic · 88d
Cleared Sep 01, 1995
GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK
K952584 · MPA
Gamp & Assoc.
Ophthalmic · 88d
Cleared Sep 01, 1995
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
K952586 · MPA
Gamp & Assoc.
Ophthalmic · 88d