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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
152929–152952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1984
PENROSE DRAINS
K841037
Inmed Corp.
General & Plastic Surgery · 44d
Cleared Apr 25, 1984
TRACHEOSTOMY CARE TRAY
K841122 · FSM
Medcare Products
General & Plastic Surgery · 41d
Cleared Apr 25, 1984
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127 · DHN
Electro-Nucleonics Laboratories, Inc.
Immunology · 40d
Cleared Apr 25, 1984
TRILICON BREASE PROSTHESIS DIFFERENT
K841171 · GBI
Baurs Krey Assoc., Inc.
General & Plastic Surgery · 37d
Cleared Apr 25, 1984
WILLIAM HARVEY H-4720 NON-FILTERED CAR
K841175 · DTN
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared Apr 25, 1984
FIBERGLASS MOUTH MIRRORS
K841199 · EAX
Henry Schein, Inc.
Dental · 35d
Cleared Apr 25, 1984
BOUNDARY SINGLE-USE GOWNS
K841255
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 30d
Cleared Apr 25, 1984
TECHMEDICA DRILL GUIDE
K841297 · FZX
Techmedica, Inc.
General & Plastic Surgery · 26d
Cleared Apr 25, 1984
HOLE CHAMFERING DEVICE
K841298 · GFF
Techmedica, Inc.
General & Plastic Surgery · 26d
Cleared Apr 25, 1984
COAGULATION FACTOR V DEFICIENT SUBSTR
K841364 · GGP
American Dade
Hematology · 23d
Cleared Apr 25, 1984
RF TEST KIT
K841454 · DHR
Difco Laboratories, Inc.
Immunology · 16d
Cleared Apr 25, 1984
BIO SPEC STREP-A-FLUOR TEST KIT
K841479 · JTO
Bio Spec, Inc.
Microbiology · 16d
Cleared Apr 25, 1984
INFECTION CONTROL VALVE
K841480 · BSY
Superior Plastic Products Corp.
Anesthesiology · 16d
Cleared Apr 25, 1984
SURGI-MED TABLE MODEL 485-LT
K841505
Midmark Corp.
General & Plastic Surgery · 15d
Cleared Apr 25, 1984
FREKATHETER VENOUS CATHETERISATION SYS
K841718
Fresenius USA, Inc.
Cardiovascular
Cleared Apr 24, 1984
COMBO UVB/UVA TANNING BOOTHS 8-40-12-36
K832482
Sun Shanty, Inc.
General & Plastic Surgery · 281d
Cleared Apr 24, 1984
ESCHMANN DILATION CATHETER
K833742
Vertex Medical Corp.
General & Plastic Surgery · 181d
Cleared Apr 24, 1984
SYSTEM 5000
K833756 · DXG
Medical Graphics Corp.
Cardiovascular · 181d
Cleared Apr 24, 1984
TOXOPLASMA GOND II IGG DIA TEST KIT
K833829 · LGD
Labsystems, Inc.
Microbiology · 173d
Cleared Apr 24, 1984
VAS-CATH DSA CATHETER/TRAY
K834232 · DQY
Vas-Cath of Canada , Ltd.
Cardiovascular · 140d
Cleared Apr 24, 1984
POSIDYNE I.V. FILTER/AIR ELIMINATOR
K834381 · FPB
Pall Biomedical Products Co.
General Hospital · 133d
Cleared Apr 24, 1984
LUMELEC ELECTRODE CATHETER
K834416 · LDF
Cordis Corp.
Cardiovascular · 131d
Cleared Apr 24, 1984
PTCA BALLOON CATHETERS & ACCESS.
K834433
Advanced Cardiovascular Systems, Inc.
General & Plastic Surgery · 139d
Cleared Apr 24, 1984
SHEATHS FOR REINFORCING BONE CEMENT
K834499
Mecron Medical Products, Inc.
General & Plastic Surgery · 126d