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
113665–113688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1993
OMNI LAPAROSCOPE
K922319 · GCJ
Expanded Optics, Inc.
General & Plastic Surgery · 340d
Cleared Apr 23, 1993
LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.
K922987 · GCJ
Biosearch Medical Products, Inc.
General & Plastic Surgery · 305d
Cleared Apr 23, 1993
IRRIGATION/SUCTION PROBE
K923667 · GBX
Surgical Instrument, Inc.
General & Plastic Surgery · 275d
Cleared Apr 23, 1993
HYBRID SURGICAL DEVICE
K924160 · GEX
Lca, Inc.
General & Plastic Surgery · 247d
Cleared Apr 23, 1993
HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY
K924281 · GCJ
Ultracision, Inc.
General & Plastic Surgery · 241d
Cleared Apr 23, 1993
THE DAVIS DISPOSABLE PROTECTIVE SPLINT
K924333 · JXL
Ora-Gard, Inc.
Neurology · 239d
Cleared Apr 23, 1993
UNIMEDIX HOLMIUM FIBER
K924424 · GEX
Unimedix, Inc.
General & Plastic Surgery · 234d
Cleared Apr 23, 1993
SELECTOR
K925129 · GCJ
Spembly Medical , Ltd.
General & Plastic Surgery · 192d
Cleared Apr 23, 1993
MODIFIED AUTO SUTURE SURGIPORT PREMIUM SEAL
K925860 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 155d
Cleared Apr 23, 1993
CANUSEAL
K925932 · GCJ
Lap Associates of Nashville, Ii, Inc.
General & Plastic Surgery · 151d
Cleared Apr 23, 1993
VALLEYLAB CURRENT MONITOR, E3350 & E3351
K926415 · GEI
Valleylab, Inc.
General & Plastic Surgery · 121d
Cleared Apr 23, 1993
VIVALUX
K926556 · EBF
Ivoclar North America, Inc.
Dental · 113d
Cleared Apr 23, 1993
ORTHOLUX XT
K930086 · EBZ
3M Company
Dental · 106d
Cleared Apr 23, 1993
THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S
K930164 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 100d
Cleared Apr 23, 1993
AE-207D TYMPANOMETER
K930165 · ETY
Amrex Electronics, Inc.
Ear, Nose, Throat · 100d
Cleared Apr 23, 1993
ACL-5500
K930210 · GEX
Ilt Systems, Inc.
General & Plastic Surgery · 98d
Cleared Apr 23, 1993
NITRATE REAGENTS A, B AND C
K930717 · JTO
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
INDOLE SPOT & INDOLE KOVACS REAGENT
K930718 · JTO
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
VOGUES-PROSKAUER REAGENT A & B
K930720 · JTO
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC
K930775 · MDM
Falcon Instruments, Inc.
General & Plastic Surgery · 66d
Cleared Apr 23, 1993
CONNECTORS AND AIRWAY EXTENSIONS
K931216 · BZA
Teknor Medical Products, Inc.
Anesthesiology · 44d
Cleared Apr 23, 1993
BREATHING FILTER
K931217 · CAH
Teknor Medical Products, Inc.
General Hospital · 44d
Cleared Apr 23, 1993
CONNECTORS AND AIRWAY EXTENSIONS
K931345 · BZA
Precision Med Products, Ltd.
Anesthesiology · 37d
Cleared Apr 22, 1993
ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
K924607 · DYB
Arrow Intl., Inc.
Cardiovascular · 223d