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
154105–154128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1984
STERILE DISPOSABLE SURGICAL GLOVES
K830635
Intermarket Latex, Inc.
General & Plastic Surgery · 335d
Cleared Jan 30, 1984
MODEL 150K LASER COAGULATOR
K832089 · HQF
Lasertek OY
Ophthalmic · 221d
Cleared Jan 30, 1984
OPHTHALMIC ARGON LASER #700A
K832316 · HQF
Laser Industries , Ltd.
Ophthalmic · 199d
Cleared Jan 30, 1984
VYGON THORACIC DRAINAGE-VARIOUS #'S
K832628 · KDD
Exco, Inc.
General & Plastic Surgery · 179d
Cleared Jan 30, 1984
ARGON LASER SYS-MODEL 5000
K832703 · HQE
Cooper Medical Corp.
Ophthalmic · 172d
Cleared Jan 30, 1984
BREAST & BODY HEALTH SYSTEM 2000
K832731 · KXZ
American Thermal Instruments, Inc.
Radiology · 179d
Cleared Jan 30, 1984
LIFEPAK 7P
K832876 · DRO
Physio-Control Corp.
Cardiovascular · 157d
Cleared Jan 30, 1984
HYPAL ADHESIVE TAPE
K832991 · KQX
Smith & Nephew, Inc.
Neurology · 150d
Cleared Jan 30, 1984
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
K833142 · CDD
Bd Becton Dickinson Vacutainer...
Chemistry · 138d
Cleared Jan 30, 1984
PROGRAMMABLE STIMULATOR 2352
K833421 · JOQ
Medtronic Vascular
Cardiovascular · 119d
Cleared Jan 30, 1984
DPC GASTRIN KIT
K833489 · CGC
Diagnostic Products Corp.
Chemistry · 115d
Cleared Jan 30, 1984
PULSE GENERATOR MODEL 688
K833519 · DXY
Burditt & Calkins-Siemens-Elema
Cardiovascular · 111d
Cleared Jan 30, 1984
LASER PHOTOCOAGULATOR 1520-A & K
K833533 · HQF
Britt Corp., Inc.
Ophthalmic · 111d
Cleared Jan 30, 1984
COMFEEL PASTE
K833565 · EXB
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 30, 1984
COLOPLAST BABY URINE COLLECTORS
K833570 · KNX
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 30, 1984
STERILE DRAINAGE SYSTEM
K833571 · EXB
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 30, 1984
HEPARIN-COATED BALLOON THERMODILUT
K833572 · DYG
Critikon Company, LLC
Cardiovascular · 110d
Cleared Jan 30, 1984
VERIFORM II
K833583 · DXN
American Medical Systems, Inc.
Cardiovascular · 110d
Cleared Jan 30, 1984
VITAL SIGNS MONITOR 3
K833584 · DPS
Physio-Control Corp.
Cardiovascular · 110d
Cleared Jan 30, 1984
TLS BULB DRAINAGE SYSTEM
K833586 · GCY
Porex Medical
General & Plastic Surgery · 110d
Cleared Jan 30, 1984
CERTAIN MANUAL SURG. INSTRU. ACCESS
K833629 · HTD
Cimed Intl., Inc.
General & Plastic Surgery · 108d
Cleared Jan 30, 1984
ACA THYROXINE UPTAKE ANALYTICAL TEST
K833703 · KHQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 104d
Cleared Jan 30, 1984
BTC URINE LH ASSAY
K833710 · CED
Btc Diagnostics, Inc.
Chemistry · 102d
Cleared Jan 30, 1984
MODEL 2000 AMBULATORY MED. INFUSER
K833723 · FRN
Parker Hannifin Corp.
General Hospital · 98d