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
87193–87216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1998
QUADRANT POSTERIOR DENSE
K984044 · EBF
Cavex Holland BV
Dental · 33d
Cleared Dec 16, 1998
MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY
K984185 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 23d
Cleared Dec 16, 1998
OSTEO 9MM IC TIBIAL NAIL
K984353 · HSB
Osteonics Corp.
Orthopedic · 9d
Cleared Dec 15, 1998
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973718 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 442d
Cleared Dec 15, 1998
ELECTRON WEDGE MODEL MT-EW-1000
K981992 · IXI
Med-Tec,Inc.
Radiology · 190d
Cleared Dec 15, 1998
ADVANTAGE WINDOWS (AW) FUSION
K983256 · LLZ
GE Medical Systems
Radiology · 90d
Cleared Dec 15, 1998
DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR
K983392 · LLZ
Data Ray
Radiology · 81d
Cleared Dec 15, 1998
FRAMEWAVE WEB
K983401 · LLZ
Ml Strategies, Inc.
Radiology · 78d
Cleared Dec 15, 1998
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER...
K983498 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 200 CALIBRATORS
K983555 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 15, 1998
ABUSCREEN ONLINE BENZ 300 CALIBRATORS
K983556 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Dec 15, 1998
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
K983601 · NFB
Medical Electronic Devices, Inc.
Anesthesiology · 62d
Cleared Dec 15, 1998
DISTAFLO BYPASS GRAFT
K983769 · DYF
Impra, Inc.
Cardiovascular · 50d
Cleared Dec 15, 1998
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05
K984318 · JJX
Bio-Rad
Chemistry · 12d
Cleared Dec 15, 1998
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
K984323 · JJX
Bio-Rad
Chemistry · 12d
Cleared Dec 15, 1998
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
K984324 · JJX
Bio-Rad
Chemistry · 12d
Cleared Dec 14, 1998
MS-900S, MS-900SPM & MS-900SFM
K980845 · DXN
Mars Medical Products
Cardiovascular · 285d
Cleared Dec 14, 1998
RTM DVT PROSOFT CUFF MODEL NUMBER PS100
K981643 · JOW
R.T. Medical Services, Inc.
Cardiovascular · 220d
Cleared Dec 14, 1998
LATEX POWDER FREE EXAMINATION GLOVES
K981942 · LYY
Maika Rubber Products Sdn Bhd
General Hospital · 195d
Cleared Dec 14, 1998
BARTELS CINAKIT CMV ANTIGENEMIA
K982311 · GQH
Intracel Corp.
Microbiology · 166d
Cleared Dec 14, 1998
ESP7 VENOUS IMAGE
K982612 · KZA
Ironmaster, Inc.
General Hospital · 140d
Cleared Dec 14, 1998
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · FYA
Medline Industries, Inc.
General Hospital · 133d
Cleared Dec 14, 1998
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
K983199 · LFL
Fibra Sonics, Inc.
General & Plastic Surgery · 91d
Cleared Dec 14, 1998
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
K983309 · LTT
Accumed Intl., Inc.
Microbiology · 84d