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
145417–145440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1986
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.
K852988 · GKZ
Technicon Instruments Corp.
Hematology · 190d
Cleared Jan 21, 1986
CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO
K853090 · EMA
Psp Dental Co., Ltd.
Dental · 182d
Cleared Jan 21, 1986
CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE
K853091 · EMA
Psp Dental Co., Ltd.
Dental · 182d
Cleared Jan 21, 1986
EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM
K853252 · BZQ
Emergent Technology Corp.
Anesthesiology · 172d
Cleared Jan 21, 1986
TROLL-BITE
K853451 · EGZ
Trollplast, Inc.
Dental · 158d
Cleared Jan 21, 1986
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
K853585 · FET
Olympus Corp.
Gastroenterology & Urology · 148d
Cleared Jan 21, 1986
LINK DYNAMIC STAPLE
K853704 · JDR
Link America, Inc.
Orthopedic · 139d
Cleared Jan 21, 1986
PASCO RESISTANT 5 PANEL
K853862 · JWY
Pasco Laboratories, Inc.
Microbiology · 126d
Cleared Jan 21, 1986
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
K854129 · LIQ
Orion Diagnostica, Inc.
Microbiology · 104d
Cleared Jan 21, 1986
ESCORT ECG MONITOR SIEMENS SIRECUST 466
K854234 · DPS
Medical Data Electronics
Cardiovascular · 92d
Cleared Jan 21, 1986
NEUROPATH 4000
K854277 · HCC
Therapeutic Technologies, Inc.
Neurology · 90d
Cleared Jan 21, 1986
7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY
K854300 · CBK
Puritan Bennett Corp.
Anesthesiology · 88d
Cleared Jan 21, 1986
HEARTECH MODEL IN TECH
K854315 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
MINIPAC (TM)
K854317 · GZJ
Medical Devices, Inc.
Neurology · 85d
Cleared Jan 21, 1986
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331 · ERL
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332 · ERL
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
THE MMG ENTERAL FEEDING ADMINISTRATION SET
K854660 · KNT
Medical Technologies of Georgia
Gastroenterology & Urology · 62d
Cleared Jan 21, 1986
LINK SMALL BONE PLATES
K854825 · HRS
Link America, Inc.
Orthopedic · 49d
Cleared Jan 21, 1986
WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS
K854886 · JEY
Walter Lorenz Surgical, Inc.
Dental · 46d
Cleared Jan 21, 1986
FRESENIUS HEMODIALYSIS MACHINE A1008 BSM
K855001 · FLC
Seratronics, Inc.
Gastroenterology & Urology · 39d
Cleared Jan 21, 1986
MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P
K855031 · HWC
Advanced Biosearch Assn.
Orthopedic · 36d
Cleared Jan 21, 1986
ANGIOMED HARZMANN DISCS
K855077 · KOD
Angiomed U.S., Inc.
Gastroenterology & Urology · 33d
Cleared Jan 21, 1986
LIFE CORP. OXYGEN PAC
K855092 · BTL
Life Corp.
Anesthesiology · 32d
Cleared Jan 21, 1986
LACTIC DEHYDROGENASE (VV) REAGENT SET
K855157 · CFJ
Technostics Intl.
Chemistry · 26d