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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
151825–151848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1984
PROTEX CONTRACEPT PLUS W/SPERM-LUB
K842185 · HIS
National Sanitary Laboratories, Inc.
Obstetrics & Gynecology · 60d
Cleared Jul 31, 1984
NATURA-TONE OR LUXOPAL CL ACRYLIC
K842208 · ELM
Parexel Intl. Corp.
Dental · 57d
Cleared Jul 31, 1984
CROWN INDEX TRAY
K842273 · EHY
Di-Equi Dental Products
Dental · 53d
Cleared Jul 31, 1984
F-G-P TRAY
K842274 · EHY
Di-Equi Dental Products
Dental · 53d
Cleared Jul 31, 1984
ISOLIGHT
K842358 · EBA
Planmeca USA, Inc.
Dental · 39d
Cleared Jul 31, 1984
MS NONPRECIOUS CROWN & BRIDGE ALLOY
K842377 · EJH
Dental Ventures of America, Inc.
Dental · 43d
Cleared Jul 30, 1984
COOK PACEMAKER CORP. 116 BIOPOLAR CARDI
K843001
Cook Pacemaker Corp.
Cardiovascular
Cleared Jul 28, 1984
INFRA-EYE 160
K841271 · LHQ
Fujitsu , Ltd.
Radiology · 123d
Cleared Jul 27, 1984
MONITOR ONE
K841172 · DSI
Qmed, Inc.
Cardiovascular · 130d
Cleared Jul 27, 1984
SUNGLASSES
K841248 · HQG
China Toy & Novelty Co., Ltd.
Ophthalmic · 150d
Cleared Jul 27, 1984
REDO CENTRAL VENOUS CATHETER-NEONATE
K841443 · LJS
Intl. Hospital Products, Inc.
General Hospital · 112d
Cleared Jul 27, 1984
PARA-TEK
K841531 · JPK
Streck Laboratories, Inc.
Hematology · 102d
Cleared Jul 27, 1984
KEYMED SIGMOIDOSCOPE SUCTION UNIT
K841822 · DRM
Keymed, Inc.
Cardiovascular · 86d
Cleared Jul 27, 1984
ENTEROPORT NUTRITION PUMP
K841827 · FRN
Diatek, Inc.
General Hospital · 85d
Cleared Jul 27, 1984
ARM-A-VIAL LV STERIAL WATER FOR INHALA
K841987 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 86d
Cleared Jul 27, 1984
ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT
K841988 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 79d
Cleared Jul 27, 1984
ARM-A-VIAL LV SODIUM CHLORIDE INHALAT
K841989 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 79d
Cleared Jul 27, 1984
ARM-A-CARE NEBULIZER-NEBULIZER
K841990 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 79d
Cleared Jul 27, 1984
ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS
K841991 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 79d
Cleared Jul 27, 1984
MIDAS II AUTOMATIC STAINER
K842077 · KPA
Innovative Medical Systems, Inc.
Hematology · 65d
Cleared Jul 27, 1984
TECHNICON TEST POINT ASSAYED HEMATOLOGY
K842109 · JPK
Technicon Instruments Corp.
Hematology · 59d
Cleared Jul 27, 1984
HISTOPAQUE-1077
K842146 · JCF
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 27, 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346 · GKL
Coulter Electronics, Inc.
Hematology · 43d
Cleared Jul 27, 1984
ECHO PULSE BURST
K842414 · GZJ
Rabar, Inc.
Neurology · 38d