FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91873–91896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1997
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
K972995 · JDI
Corin USA
Orthopedic · 90d
Cleared Nov 10, 1997
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION
K972997 · IPF
Dan Med, Inc.
Physical Medicine · 90d
Cleared Nov 10, 1997
THE CORIFIX LIGAMENT ANCHOR
K973005 · HWC
Corin USA
Orthopedic · 89d
Cleared Nov 10, 1997
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009 · MBI
Mitek Products
Orthopedic · 89d
Cleared Nov 10, 1997
REALTIME 3D DIAGNOSTIC WORKSTATION
K973010 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 10, 1997
SYNTHES MINI LENGTHENING APPARATUS
K973018 · MQN
Synthes (Usa)
Dental · 89d
Cleared Nov 10, 1997
INTELECT LEGEND ULTRASOUND
K973024 · IMI
Chattanooga Group, Inc.
Physical Medicine · 88d
Cleared Nov 10, 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER...
K973113 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 82d
Cleared Nov 10, 1997
MAMMOTEST ADAPTER DRIVER
K973400 · IZH
Fischer Imaging Corp.
Radiology · 62d
Cleared Nov 10, 1997
KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER
K973476 · EHD
Eastman Kodak Company
Radiology · 56d
Cleared Nov 10, 1997
PHILIPS INTEGRIS V5000 AND BV5000
K973482 · IZI
Philips Medical Systems North...
Radiology · 56d
Cleared Nov 10, 1997
PLANMED CYTOGUIDE
K973493 · IZH
Planmed OY
Radiology · 56d
Cleared Nov 10, 1997
SIREMOBIL CO2
K973598 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Nov 10, 1997
INFLATABLE POSITIONING CUSHIONS
K973915 · IZH
Kci New Technologies, Inc.
Radiology · 27d
Cleared Nov 10, 1997
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K974075 · MMI
Beckman Instruments, Inc.
Chemistry · 12d
Cleared Nov 07, 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · KNT
Abbott Laboratories
Gastroenterology & Urology · 494d
Cleared Nov 07, 1997
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
K970081 · FNM
Cathay Consolidated, Inc.
General Hospital · 302d
Cleared Nov 07, 1997
O2 BOOT
K971507 · KPJ
Gwr Medical, Llp
General & Plastic Surgery · 196d
Cleared Nov 07, 1997
LOW PROFILE FEEDING SET ACCESSORY
K971757 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 178d
Cleared Nov 07, 1997
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
K971836 · HET
CooperSurgical, Inc.
Obstetrics & Gynecology · 172d
Cleared Nov 07, 1997
GESCO PER-Q-CATH PICC CATHETERS
K971990 · FOZ
Bard Access Systems, Inc.
General Hospital · 182d
Cleared Nov 07, 1997
GESCO PER-Q-CATH MIDLINE CATHETERS
K971991 · FOZ
Bard Access Systems, Inc.
General Hospital · 182d
Cleared Nov 07, 1997
ACUITY CENTRAL STATION
K972121 · MLD
Protocol Systems, Inc.
Cardiovascular · 155d
Cleared Nov 07, 1997
STERI-OSS UNTIL IMPLANT CEMENT
K972965 · EMA
Steri-Oss, Inc.
Dental · 88d