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
108313–108336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1994
NYLON LINER GLOVES
K940274 · LYU
Wells Lamont Corp.
General Hospital · 111d
Cleared May 12, 1994
SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
K940346 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 107d
Cleared May 12, 1994
HYDRO-M(TM) WOUND GEL
K940814 · MGQ
Kingston Technologies, Inc.
General & Plastic Surgery · 79d
Cleared May 12, 1994
WAX GUARD OPTION
K941039 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 70d
Cleared May 12, 1994
AUDIOTONE MODEL A-54
K941121 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
AUDIOTONE MODEL A-54SR
K941122 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
770-ATC
K941133 · ESD
Electone, Inc.
Ear, Nose, Throat · 64d
Cleared May 12, 1994
ONTRAC STEERABLE GUIDEWIRE
K941229 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 58d
Cleared May 12, 1994
SHARP II FULL CONTOUR
K941292 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
SHARP II SEMI CONTOUR HEARING AID
K941293 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
SHARP II LOW PROFILE HEARING AID
K941294 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 56d
Cleared May 12, 1994
STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE
K941302 · KKX
Cush Industries, Inc.
General Hospital · 56d
Cleared May 12, 1994
LAP SPONGE PRODUCT LINE
K941344 · GDY
Cush Medical Products
General & Plastic Surgery · 56d
Cleared May 12, 1994
WOUND DRESSING KIT
K941467 · FRG
Clinical Resources, Inc.
General Hospital · 45d
Cleared May 12, 1994
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
K941468 · FRG
Clinical Resources, Inc.
General Hospital · 45d
Cleared May 12, 1994
IV START KIT
K941469 · LRS
Clinical Resources, Inc.
General & Plastic Surgery · 45d
Cleared May 12, 1994
CENTRAL LINE DRESSING CHANGE TRAY
K941471 · FRG
Clinical Resources, Inc.
General Hospital · 45d
Cleared May 12, 1994
STERILE X-RAY DETECTABLE GAUZE SPONGES
K941522 · GDY
Cush Medical Products
General & Plastic Surgery · 43d
Cleared May 12, 1994
PEARL PACKING FORCEPS
K941528 · HCZ
Cook Urological, Inc.
Obstetrics & Gynecology · 43d
Cleared May 12, 1994
ISL QC 2000 LASER
K941694 · GEX
Intelligent Surgical Lasers, Inc.
General & Plastic Surgery · 36d
Cleared May 12, 1994
LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S
K941955 · EFQ
Lorrex Health Products
General & Plastic Surgery · 20d
Cleared May 11, 1994
JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT
K925467 · LRO
J.J. Skinner, Inc.
General & Plastic Surgery · 559d
Cleared May 11, 1994
KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES
K935785 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 156d
Cleared May 11, 1994
SYN ENA SCREEN (PIN PLATE)
K940229 · LLL
Elias U.S.A., Inc.
Immunology · 113d