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
143185–143208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1986
APLICARE SKIN PROTECTANT PREP PAD
K861557 · NEC
Aplicare, Inc.
General & Plastic Surgery · 77d
Cleared Jul 11, 1986
SERIES TEN THOUSAND COMPACT
K861565 · HQE
CooperVision, Inc.
Ophthalmic · 77d
Cleared Jul 11, 1986
MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
K861822 · GWO
Valley Forge Scientific Corp.
Neurology · 60d
Cleared Jul 11, 1986
CURITY CENTRAL VENOUS CATHETERIZATION TRAY
K861827 · DQY
The Kendal Co.
Cardiovascular · 60d
Cleared Jul 11, 1986
REFLOTRON URIC ACID
K861831 · KNK
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jul 11, 1986
OPM SLIT LAMP MODEL P-1
K861854 · HJO
Optek Medico Co., Ltd.
Ophthalmic · 58d
Cleared Jul 11, 1986
SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM
K862024 · HKS
Ocular Instruments, Inc.
Ophthalmic · 44d
Cleared Jul 11, 1986
DELFIA (TM) HCG KIT
K862044 · JHJ
Lkb Instruments, Inc.
Chemistry · 44d
Cleared Jul 11, 1986
KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD
K862057 · KWY
Kirschner Medical Corp.
Orthopedic · 42d
Cleared Jul 11, 1986
DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER)
K862128 · KQX
Health Products, Inc.
Neurology · 37d
Cleared Jul 11, 1986
INTERNATIONAL TOTAL HIP SYSTEM
K862225 · JDI
Richards Medical Co., Inc.
Orthopedic · 30d
Cleared Jul 11, 1986
TDX BENZODIAZEPINES
K862250 · JXM
Abbott Laboratories
Toxicology · 29d
Cleared Jul 11, 1986
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298 · DRO
Medtronic Vascular
Cardiovascular · 24d
Cleared Jul 11, 1986
SENTEC LASER GUIDE LINE, MODEL SGL-05
K862340 · IZW
Sentec Corp.
Radiology · 21d
Cleared Jul 11, 1986
VACUUM HANDLE MODEL I/A - 1
K862343 · HQE
Cutler Medical Instruments
Ophthalmic · 21d
Cleared Jul 11, 1986
ENDOTRACHEAL TUBE, ACCESSORY
K862347 · BTR
Sheridan Catheter Corp.
Anesthesiology · 21d
Cleared Jul 11, 1986
EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95
K862403 · DKB
Diagnostic Systems
Toxicology · 15d
Cleared Jul 11, 1986
SNAP-ON TORQUER
K862409 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 16d
Cleared Jul 11, 1986
PRECEPT CEFTAZIDIME
K862446 · JWY
Austin Biological Laboratories
Microbiology · 14d
Cleared Jul 11, 1986
MASUNAGA OPTICAL MANUFACTURING
K862502 · HQZ
South West Intl., Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
KOELN OPTIK
K862503 · HQZ
South West Intl., Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
RITCH TRABECULOPLASTY LASER LENS
K862512 · HKS
Ocular Instruments, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
BAUSCH & LOMB CSL-1000 SLIT LAMP
K862515 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
BAUSCH & LOMB OSL-2000 SLIT LAMP
K862516 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 10d