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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
107353–107376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1994
HAE 1
K942829 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
HAE 3
K942830 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
HAE 2
K942831 · ESD
Hearing Aid Express
Ear, Nose, Throat · 36d
Cleared Jul 20, 1994
CONMED ANDOVER MED ECG ELECTRODES
K942925 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 28d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL CURETTE
K942967 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL OSTEOTOME
K942968 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL NERVE HOOK
K942969 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL ELEVATOR
K942970 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL DISSECTOR
K942971 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AURIS CIC
K943144 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 19, 1994
BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE
K925098 · HTY
Bioscience, Inc.
Orthopedic · 649d
Cleared Jul 19, 1994
MICRON-SCOPE II
K926412 · HMS
Chiron Vision Corp.
Ophthalmic · 575d
Cleared Jul 19, 1994
VITALMAX 530
K932203 · DQA
Pace Tech Medical Monitors, Inc.
Anesthesiology · 439d
Cleared Jul 19, 1994
VITALMAX 4000
K933624 · MHX
Pace Tech, Inc.
Cardiovascular · 365d
Cleared Jul 19, 1994
BII-PORE
K933688 · LYC
Bio-Interfaces, Inc.
Dental · 355d
Cleared Jul 19, 1994
STB YANKAUER SUCKER/NOZZLE
K933762 · JOL
Save-T-Breath Distributors C.C.
General Hospital · 350d
Cleared Jul 19, 1994
BII-PORE(TM) CANAL WALL PROSTHESIS
K934049 · LYC
Bio-Interfaces, Inc.
Dental · 334d
Cleared Jul 19, 1994
HYSTEROSCOPE
K934286 · HIH
Bei Medical Systems Co., Inc.
Obstetrics & Gynecology · 320d
Cleared Jul 19, 1994
KOLSTER METHODS
K935820 · HGH
Kolster Methods
Obstetrics & Gynecology · 228d
Cleared Jul 19, 1994
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K936016 · GGT
R&D Systems, Inc.
Hematology · 215d
Cleared Jul 19, 1994
ACT CONTROL SET
K940840 · JPA
Sigma Diagnostics, Inc.
Hematology · 146d
Cleared Jul 19, 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971 · LCP
Heraeus Kulzer, Inc.
Hematology · 139d
Cleared Jul 19, 1994
SPLASH MASK
K941932 · LYU
Incon Diversified Industries, Inc.
General Hospital · 90d
Cleared Jul 19, 1994
SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
K941984 · FRN
Sabratek Corp.
General Hospital · 85d