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
133177–133200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1988
KTP/532 SURGICAL LASER
K884029 · GEX
Laserscope
General & Plastic Surgery · 63d
Cleared Nov 25, 1988
DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP
K884656 · GEI
Dermacare
General & Plastic Surgery · 18d
Cleared Nov 23, 1988
POLYSCAN DIGITAL SCANNER
K882453 · IYW
Medical and Scientific Enterprises, Inc.
Radiology · 162d
Cleared Nov 23, 1988
ULTRASONIC IMAGING CATHETER
K883202 · DXO
Boston Scientific Corp
Cardiovascular · 118d
Cleared Nov 23, 1988
VOXEL FLINGER(TM) 3-D IMAGING SYSTEM
K883476 · LLZ
Reality Imaging Corp.
Radiology · 99d
Cleared Nov 23, 1988
BERICHROM(R) ANTITHROMBIN III
K883662 · JBQ
Behring Diagnostics, Inc.
Hematology · 89d
Cleared Nov 23, 1988
MAGNETOM (M, H, 42, 63) SEQUENCES
K884062 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Nov 23, 1988
DISKCAM DC 6001
K884148 · LMB
Camtronics, Ltd.
Radiology · 51d
Cleared Nov 23, 1988
NIDEK LM-870 AUTOMATIC LENSMETER
K884188 · HLM
Nidek, Inc.
Ophthalmic · 49d
Cleared Nov 23, 1988
NICOLET NYSTAR PLUS SYSTEM
K884294 · GWN
Nicolet Instrument Corp.
Neurology · 42d
Cleared Nov 23, 1988
E.T. PUFFER
K884374 · BZA
Kalajian Ent.
Anesthesiology · 36d
Cleared Nov 23, 1988
PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR
K884541 · IPL
Pro-Vertic, Inc.
Physical Medicine · 23d
Cleared Nov 23, 1988
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638 · BSK
Instrumentation Industries, Inc.
Anesthesiology · 16d
Cleared Nov 22, 1988
GHB SAMPLE PAPER
K880673 · LCP
Isolab, Inc.
Hematology · 277d
Cleared Nov 22, 1988
ACCUTEMP PLUS
K881670 · FMT
Sentry Medical Products, Inc.
General Hospital · 218d
Cleared Nov 22, 1988
NEEDLE EJECTOR
K881867 · FMF
Howard, Hills & Harsh
General Hospital · 203d
Cleared Nov 22, 1988
LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
K883212 · KXA
Implant Technology, Inc.
Orthopedic · 116d
Cleared Nov 22, 1988
TENSIOMETER
K883694 · LXH
W.L. Gore & Associates, Inc.
Orthopedic · 85d
Cleared Nov 22, 1988
MSI-CAL 7
K883703 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 22, 1988
FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309
K883822 · HMP
Consolidated Industries of Greater...
General & Plastic Surgery · 76d
Cleared Nov 22, 1988
MSI-CAL 16
K883850 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 22, 1988
MSI-CAL 8
K883851 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 22, 1988
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
K884191 · GNX
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Nov 22, 1988
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
K884192 · LKT
Baxter Diagnostics, Inc.
Microbiology · 47d