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
131593–131616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1989
SPECBOARD
K891090 · IZH
Macbrud Corp. Medical Div.
Radiology · 32d
Cleared Apr 07, 1989
SODIUM BICARBONATE, U.S.P.
K891159 · KPO
Williams Medical Co.
Gastroenterology & Urology · 32d
Cleared Apr 07, 1989
BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET
K891406 · LJE
Cook Urological, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 07, 1989
PRECEPT MICRO-GARD LASER MASK
K891409 · FXX
Mars White Knight
General Hospital · 24d
Cleared Apr 07, 1989
C-52 GOLD BASE DENTAL ALLOY
K891515 · EJT
Macdonald Metals and Ceramics
Dental · 21d
Cleared Apr 07, 1989
M-56 GOLD BASE DENTAL ALLOY
K891526 · EJT
Macdonald Metals and Ceramics
Dental · 21d
Cleared Apr 07, 1989
ORTHODONTIC ARCH AND SURGICAL HOOKS
K891592 · EJF
American Orthodontics
Dental · 18d
Cleared Apr 07, 1989
GOLD CLASS, GRANDTEX, LATEX EXAMINATION GLOVES
K891648 · LYY
Harry Panzer Intl. Corp.
General Hospital · 21d
Cleared Apr 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891743 · LYY
Dispotex Industries Sdn. Bhd.
General Hospital · 16d
Cleared Apr 07, 1989
DA-46 FLUID BARRIER
K891752 · FIB
Akcess Medical Products, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 07, 1989
DC-4 SHUNT INFUSION T
K891754 · FKB
Akcess Medical Products, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 07, 1989
FC-100 FEMORAL CATHETER
K891763 · LFK
Akcess Medical Products, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 07, 1989
FC-101 FEMORAL CATHETER GUIDE WIRE
K891764 · LFK
Akcess Medical Products, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 06, 1989
TSRH SACRAL SPINAL SCREW
K883783 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 212d
Cleared Apr 06, 1989
TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
K883784 · LYQ
Warsaw Orthopedic, Inc.
Orthopedic · 212d
Cleared Apr 06, 1989
KATZEN THROMBOLYSIS GUIDEWIRE
K883880 · DQX
Medi-Tech, Inc.
Cardiovascular · 205d
Cleared Apr 06, 1989
PHACOEMULSIFIER MODEL 100
K890080 · HQC
Sonic Needle Corp.
Ophthalmic · 87d
Cleared Apr 06, 1989
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141 · NFB
Devilbiss Health Care, Inc.
Anesthesiology · 83d
Cleared Apr 06, 1989
C-S IMPACTOR
K890185 · LYP
Orthopedic Systems, Inc.
Orthopedic · 78d
Cleared Apr 06, 1989
THE C-S DISTRACTION ROD ASSEMBLY
K890187 · KWP
Orthopedic Systems, Inc.
Orthopedic · 78d
Cleared Apr 06, 1989
LATEX EXAMINATION GLOVES NON-STERILE
K890356 · LYY
Quest Intl., Inc.
General Hospital · 72d
Cleared Apr 06, 1989
VINYL PATIENT EXAMINATION GLOVE
K890987 · LYZ
Jm Gloves Co., Ltd.
General Hospital · 36d
Cleared Apr 06, 1989
PATIENT EXAMINATION GLOVE
K891017 · LYY
Paramount Products, Inc.
General Hospital · 37d
Cleared Apr 06, 1989
KIRSCHNER RETRACTOR
K891031 · GAD
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 37d