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
170305–170328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 1978
MULAR GOLD LEAF ELECTRODE MODEL 7501
K781476 · HLZ
Life-Tech Instruments, Inc.
Ophthalmic · 79d
Cleared Nov 15, 1978
PLASMINOGEN ASSAY
K781478 · DDX
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 79d
Cleared Nov 15, 1978
RETINOMETER
K781507 · HPJ
Coburn Optical Ind., Inc.
Ophthalmic · 75d
Cleared Nov 15, 1978
AIR POWERED DENTAL HANDPIECE
K781545 · EFB
Promident Mfg., Ltd.
Dental · 64d
Cleared Nov 15, 1978
HEMACHECK
K781562 · GKL
Vickers America Medical Corp.
Chemistry · 65d
Cleared Nov 15, 1978
MACRO-VUE TEST, GENTAMICIN
K781674 · DJB
Bd Becton Dickinson Vacutainer...
Toxicology · 43d
Cleared Nov 15, 1978
REFLECT IMPRESSION MATERIAL
K781689 · ELW
Kerr Corporation (Danbury)
Dental · 42d
Cleared Nov 15, 1978
CALIBRATOR, BOVINE SERUM
K781702 · JIX
Bio-Reagents & Diagnostics, Inc.
Chemistry · 36d
Cleared Nov 15, 1978
QUANTICEL HHR, L531 AND L532
K781745 · JPK
Bhp Diagnostix, Inc.
Hematology · 26d
Cleared Nov 15, 1978
SILASTIC H.P. TRAPEXIAL IMPLANT
K781756 · KYI
Dow Corning Corp. Healthcare...
Orthopedic · 30d
Cleared Nov 15, 1978
SKIN MARKING PEN
K781770 · FZZ
Abco Dealers, Inc.
General & Plastic Surgery · 30d
Cleared Nov 15, 1978
QUANTICEL HHR # L500 AND L501
K781786 · JPK
Bhp Diagnostix, Inc.
Hematology · 27d
Cleared Nov 15, 1978
LAPARATOMY SPONGE
K781818 · GDY
Meden Medical Sales Division
General & Plastic Surgery · 19d
Cleared Nov 15, 1978
BIOPSY KIT 781101, ASPIRATION
K781830 · HHK
Vista Products, Inc.
Obstetrics & Gynecology · 15d
Cleared Nov 15, 1978
WOUND SPAN BRIDGE III
K781837 · KAS
Howmedica Corp.
Ear, Nose, Throat · 16d
Cleared Nov 15, 1978
GLOVE, SUPERFLEX MOLDED
K781852 · KPY
Pinnacle Distributors, Inc.
Radiology · 9d
Cleared Nov 15, 1978
FILTER, EXTRACORPOREAL BLOOD HOLDER
K781861 · KRI
Surgikos, Inc.
Cardiovascular · 9d
Cleared Nov 15, 1978
CANNULA CADDY
K781866
Katena Products, Inc.
General & Plastic Surgery · 12d
Cleared Nov 15, 1978
HEARING AID, MODEL 781
K781881 · ESD
Danavox, Inc.
Ear, Nose, Throat · 9d
Cleared Nov 15, 1978
PIPETTES, PLASTIC DISPOSABLE
K781891 · GJG
Hillwood Corp.
Hematology · 7d
Cleared Nov 14, 1978
TEMPERATURE CONTROLLER MODEL 17000
K781530 · BZE
Healthdyne, Inc.
Anesthesiology · 69d
Cleared Nov 14, 1978
CATHETERS, H-H ATRIAL AND PERITONEAL
K781768 · JXG
Holter-Hausner Intl.
Neurology · 29d
Cleared Nov 14, 1978
EXERCISER, AIR-EZE INCENTIVE
K781833 · BWF
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 15d
Cleared Nov 08, 1978
ACCUSCREEN T4
K781222 · CDX
Neometrics, Inc.
Chemistry · 114d