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
84265–84288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 13, 1999
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT...
K991205 · KGO
Allegiance Healthcare Corp.
General Hospital · 187d
Cleared Oct 13, 1999
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE,...
K991563 · HIH
Henke Sass Wolf of America, Inc.
Obstetrics & Gynecology · 161d
Cleared Oct 13, 1999
SYNERGY INTEGRAL SCREWS, MODELS,...
K992369 · MNI
Interpore Cross Intl.
Orthopedic · 90d
Cleared Oct 13, 1999
THE LEADAWAY
K992372 · IKD
Therapy Equipment, Inc.
Physical Medicine · 90d
Cleared Oct 13, 1999
ENDO-EZE MOTOR AND HANDPIECE
K992380 · EFB
Ultradent Products, Inc.
Dental · 89d
Cleared Oct 13, 1999
RAYPAX WEB CLINICAL SYSTEM
K992426 · LMD
Samsung Sds Co., Ltd.
Radiology · 84d
Cleared Oct 13, 1999
NEO-2 METER
K992431 · FIZ
Automata Instrumentation, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 13, 1999
URETERO-RENOSCOPE
K992527 · FGB
Fiber Imaging Technologies, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 13, 1999
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
K992547 · MQB
Canon USA, Inc.
Radiology · 75d