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
84769–84792 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1999
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA
K993148 · FYA
Stryker Instruments
General Hospital · 24d
Cleared Oct 15, 1999
OBC-085 BREAST ARRAY COIL
K993233 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 15, 1999
QWH-085 WRIST ARRAY COIL
K993235 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 15, 1999
QSC-085 SHOULDER ARRAY COIL
K993279 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Oct 14, 1999
ZIPPY
K983808 · ITI
Pillar Technology, Inc.
Physical Medicine · 351d
Cleared Oct 14, 1999
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
K990372 · HET
Dr. Fritz GmbH
Obstetrics & Gynecology · 248d
Cleared Oct 14, 1999
CONTOUR SPINAL SYSTEM
K990986 · KWP
Ortho Development Corp.
Orthopedic · 204d
Cleared Oct 14, 1999
SIMPLICARE TRANSPARENT WOUND DRESSING
K991214 · MGP
Hollister, Inc.
General & Plastic Surgery · 188d
Cleared Oct 14, 1999
ECOMED SCALP VEIN SET
K992145 · FPA
Greiner Meditech, Inc.
General Hospital · 112d
Cleared Oct 14, 1999
SURGITRON RADIOLASE
K992382 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 90d
Cleared Oct 14, 1999
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
K992458 · MBI
Innovasive Devices, Inc.
Orthopedic · 83d
Cleared Oct 14, 1999
RCNG: ROOT CANAL NEGOTIATING GEL
K992484 · KJJ
Jordco, Inc.
Dental · 80d
Cleared Oct 14, 1999
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992555 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 76d
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CEFOTAXIME
K992568 · JTN
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Oct 14, 1999
PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL
K992593 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Oct 14, 1999
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210,...
K992612 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 71d
Cleared Oct 14, 1999
NEUROFAX, MODEL EEG-1100A
K992742 · OLV
Nihon Kohden America, Inc.
Neurology · 59d
Cleared Oct 14, 1999
ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103
K992764 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 58d
Cleared Oct 14, 1999
ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110,...
K992769 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 58d
Cleared Oct 14, 1999
HICHEM BUN REAGENT
K992847 · LFP
Elan Holdings, Inc.
Chemistry · 51d
Cleared Oct 14, 1999
GLUMA COMFORT BOND
K992985 · KLE
Heraeus Kulzer, Inc.
Dental · 41d
Cleared Oct 14, 1999
CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15
K993002 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 37d
Cleared Oct 14, 1999
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
K993089 · FTA
Deroyal Cardiovascular, Inc.
General & Plastic Surgery · 28d
Cleared Oct 14, 1999
MAXIM KNEE SYSTEM
K993159 · JWH
Biomet, Inc.
Orthopedic · 23d