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
84553–84576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 13, 1999
CORTICAL MAPPING UNIT, MODEL CMU
K992194 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 76d
Cleared Sep 13, 1999
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER...
K992307 · MQF
Fertility Technology Resources, Inc.
Obstetrics & Gynecology · 66d
Cleared Sep 13, 1999
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
K992308 · MQE
Lifetek Medical, Inc.
Obstetrics & Gynecology · 66d
Cleared Sep 13, 1999
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
K992311 · DCK
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Sep 13, 1999
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
K992312 · DCK
Kamiya Biomedical Co.
Immunology · 66d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING...
K992417 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH...
K992418 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH...
K992419 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 13, 1999
COLLINS CPL
K992743 · BZG
Collins Medical, Inc.
Anesthesiology · 28d