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
98809–98832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1996
CPR LACERATION TRAY
K960207 · FRG
Custom Pack Reliability
General Hospital · 42d
Cleared Feb 27, 1996
EXPANDACELL INJECTO-PAK NASAL PACK
K960228 · EMX
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 41d
Cleared Feb 27, 1996
BIPOLAR SUCTION COAGULATOR
K960455 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 28d
Cleared Feb 26, 1996
KERATIN PRIMARY ANTIBODY
K940331 · DEH
Ventana Medical Systems, Inc.
Immunology · 763d
Cleared Feb 26, 1996
AURORA IMAGING SYSTEM
K950837 · LNH
Advanced Mammography Systems, Inc.
Radiology · 367d
Cleared Feb 26, 1996
COMPUTE-RX PLAN PC3D
K953508 · IYE
Medicalibration Physics Consultant...
Radiology · 215d
Cleared Feb 26, 1996
ANGIOFLUSH II FLUID MANAGEMENT SYSTEM
K953825 · FPA
AngioDynamics, Inc.
General Hospital · 195d
Cleared Feb 26, 1996
OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
K954208 · JWH
Exactech, Inc.
Orthopedic · 172d
Cleared Feb 26, 1996
SPECTEF PROTOCOL
K954874 · KPS
GE Medical Systems
Radiology · 125d
Cleared Feb 26, 1996
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
K955508 · LKF
Cook Urological, Inc.
Obstetrics & Gynecology · 87d
Cleared Feb 26, 1996
ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
K955511 · LPH
Joint Medical Products Corp.
Orthopedic · 84d
Cleared Feb 26, 1996
DIAMOND (CODE NAME PT-054)
K960403 · EJT
J.F. Jelenko & Co., Inc.
Dental · 28d
Cleared Feb 26, 1996
C & B METABOND (MODIFICATION)
K960464 · EMA
Parkell, Inc.
Dental · 27d
Cleared Feb 26, 1996
VENTILATION TUBES
K960477 · ETD
Smith & Nephew, Inc.
Ear, Nose, Throat · 25d
Cleared Feb 23, 1996
IMMULITE TOXOPLASMA GONDII IGG
K950671 · LGD
Diagnostic Products Corp.
Microbiology · 375d
Cleared Feb 23, 1996
CARACELL
K953118 · CAC
Medtronic Vascular
Anesthesiology · 235d
Cleared Feb 23, 1996
SCIMED DISPATCH CORONARY INFUSION CATHETER
K953133 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 232d
Cleared Feb 23, 1996
SERAQUEST CMV IGG
K954191 · LFZ
Quest Intl., Inc.
Microbiology · 170d
Cleared Feb 23, 1996
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K954512 · DZE
Lifecore Biomedical, Inc.
Dental · 148d
Cleared Feb 23, 1996
DSL AACTIVE DHEA EIA KIT
K955114 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 106d
Cleared Feb 23, 1996
EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER
K955374 · JGS
Medica Corp.
Chemistry · 91d
Cleared Feb 23, 1996
EASYSTAT SODIUM/POTASSIUM ANALYZER
K955375 · JGS
Medica Corp.
Chemistry · 91d
Cleared Feb 23, 1996
EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
K955448 · DLB
Behring Diagnostics, Inc.
Toxicology · 86d
Cleared Feb 23, 1996
OPUS PROLACTIN CONTROLS
K955468 · JJX
Behring Diagnostics, Inc.
Chemistry · 85d