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
85057–85080 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1999
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT...
K991125 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 165d
Cleared Sep 14, 1999
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES,...
K991419 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 144d
Cleared Sep 14, 1999
CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400
K991529 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 134d
Cleared Sep 14, 1999
LUMENON XENON LIGHT SOURCE
K992050 · GCT
Walter Lorenz Surgical, Inc.
Gastroenterology & Urology · 89d
Cleared Sep 14, 1999
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K992110 · KWQ
Sofamor Danek USA
Orthopedic · 84d
Cleared Sep 14, 1999
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH...
K992128 · LYY
Dash Medical Gloves Sdn Bhd
General Hospital · 83d
Cleared Sep 14, 1999
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K992171 · KGO
Allegiance Healthcare Corp.
General Hospital · 78d
Cleared Sep 14, 1999
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
K992302 · MGP
Dermaphylyx, Inc.
General & Plastic Surgery · 68d
Cleared Sep 14, 1999
SCHOELLY RIGID ENDOSCOPES
K992437 · GCJ
Fiber Imaging Technologies, Inc.
General & Plastic Surgery · 54d
Cleared Sep 14, 1999
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992464 · LYZ
Shijiazhuang Dilly Plastics Products...
General Hospital · 53d
Cleared Sep 14, 1999
XENON LIGHT SOURCE PES 1
K992540 · GCT
Laser Optik Systeme GmbH & Co. KG
Gastroenterology & Urology · 47d
Cleared Sep 14, 1999
QUALATEX POWDERED LATEX EXAMINATION GLOVES
K992557 · LYY
Tan Sin Lian Industries Sdn. Bhd.
General Hospital · 46d
Cleared Sep 14, 1999
CONTROL III ELITE
K992661 · LRJ
Maril Products, Inc.
General Hospital · 36d
Cleared Sep 14, 1999
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K992730 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 32d
Cleared Sep 14, 1999
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
K992807 · GWJ
Bio-Logic Systems Corp.
Neurology · 25d
Cleared Sep 14, 1999
AEROCHAMBER PLUS VALVED HOLDING CHAMBER
K992917 · CAF
Trudell Medical Int'L
Anesthesiology · 15d
Cleared Sep 13, 1999
ENDO-SPOR PLUS / HYPROCIDE
K972708 · MED
Cottrell, Ltd.
General Hospital · 784d
Cleared Sep 13, 1999
KION ANESTHESIA SYSTEM
K973971 · BSZ
Siemens Medical Solutions USA, Inc.
Anesthesiology · 696d
Cleared Sep 13, 1999
ORATEC BIPOLAR ABLATION PROBES
K991218 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 154d
Cleared Sep 13, 1999
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES,...
K991388 · MQH
Pacific Andrology, Inc.
Obstetrics & Gynecology · 145d
Cleared Sep 13, 1999
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
K991799 · HIG
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 110d
Cleared Sep 13, 1999
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
K992057 · BTM
Sims Portex, Inc.
Anesthesiology · 87d
Cleared Sep 13, 1999
BIO-MODULAR SHOULDER SYSTEM
K992119 · KWS
Biomet, Inc.
Orthopedic · 82d
Cleared Sep 13, 1999
SAMSUNG RAYPAX LONG TERM ARCHIVE
K992131 · LMB
Samsung Sds Co., Ltd.
Radiology · 82d