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
151633–151656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1984
LACTALBUMIN HYDROLYSATE MED. CATALOG
K843045 · KIT
Sigma Chemical Co.
Chemistry · 10d
Cleared Aug 10, 1984
PERIPHERAL DILATATION ANGIOPLASTY-CATH
K834429 · LIT
American Edwards Laboratories
Cardiovascular · 239d
Cleared Aug 10, 1984
HELENA COLOSCREEN SELF-TEST
K840903 · KHE
Helena Laboratories
Hematology · 164d
Cleared Aug 10, 1984
ESCHWEILER COMBI-ANALYSER MTA-500
K840961 · CEM
U.S. Science, Inc.
Chemistry · 157d
Cleared Aug 10, 1984
COMPUTER, CENTRAL PROCESSING UNIT
K841261 · DXG
Nem Computer Corp.
Cardiovascular · 137d
Cleared Aug 10, 1984
MULTIPRO CATHETER
K841797 · DQY
Shiley, Inc.
Cardiovascular · 109d
Cleared Aug 10, 1984
TISSUE INTEGRATED PROSTHESIS DRILL
K841813 · ERL
Bofors Nobelpharma, Inc.
Ear, Nose, Throat · 101d
Cleared Aug 10, 1984
DCX-100 CHEST UNIT-GL-5000M
K841923 · KPR
Transworld X-Ray Corp.
Radiology · 92d
Cleared Aug 10, 1984
RADIOEAR M420H
K841933 · ESD
Radioear Corp.
Ear, Nose, Throat · 91d
Cleared Aug 10, 1984
SARNS EVACUPLEGE CATHETER
K842044 · DWE
3M Health Care, Sarns
Cardiovascular · 81d
Cleared Aug 10, 1984
TOYO JOZO G-GTP TEST
K842104 · JPZ
Advocacy International, Ltd.
Chemistry · 77d
Cleared Aug 10, 1984
LEE BONE MARROW NEEDLES
K842106 · GAA
Southland Instruments, Inc.
General & Plastic Surgery · 77d
Cleared Aug 10, 1984
DMI ASPIRATOR 500
K842204 · BTA
Dean Medical Instruments, Inc.
General & Plastic Surgery · 67d
Cleared Aug 10, 1984
VENOUS CANNULA W/BENT, TIP WIRE
K842375 · DWF
Dlp, Inc.
Cardiovascular · 53d
Cleared Aug 10, 1984
ELECTRO-SAGE MODEL 203
K842379 · IRO
Weingart, Inc.
Physical Medicine · 53d
Cleared Aug 10, 1984
3M RAPIDSTAT LIGATING CLIP SYS
K842382 · FZP
3M Company
General & Plastic Surgery · 53d
Cleared Aug 10, 1984
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT
K842482 · CEC
Amersham Corp.
Chemistry · 46d
Cleared Aug 10, 1984
OPTICLEAR
K842485 · JJN
Gelman Sciences, Inc.
Chemistry · 46d
Cleared Aug 10, 1984
SDC SILICONE FORCEP SHODS PRODUCT
K842491
Science Development Corp.
General & Plastic Surgery · 45d
Cleared Aug 10, 1984
ICP/6500 INDUCTIVELY-COUPLED PLASMA-
K842496 · JXR
The Perkin-Elmer Corp.
Toxicology · 45d
Cleared Aug 10, 1984
GAMBRO PULSATILE MONITOR PLM 10-200
K842503 · DWA
Gambro, Inc.
Cardiovascular · 45d
Cleared Aug 10, 1984
ADVANCED CARDIOVASCULAR BALLOON DILATA
K842556 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 39d
Cleared Aug 10, 1984
OPTIPHOR-10
K842560 · JJN
Gelman Sciences, Inc.
Chemistry · 39d
Cleared Aug 10, 1984
T.P.G. CAST TAPE
K842573 · ITG
The Poly Group, Inc.
Physical Medicine · 38d