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
168913–168936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1979
STRESS/EMERGENCY EELCTRODE
K790883
Hayes Products, Inc.
Neurology · 76d
Cleared Jul 24, 1979
MISTY NEBULIZER
K790892 · CAF
Airlife, Inc.
Anesthesiology · 78d
Cleared Jul 24, 1979
ANTI-DNASE B REAGENT SYSTEM
K790997 · GTR
Calbiochem-Behring Corp.
Microbiology · 56d
Cleared Jul 24, 1979
PROTHROMBIN REFERENCE PLASMA (HUMAN)
K791022 · GJS
Pacific Hemostasis
Hematology · 55d
Cleared Jul 24, 1979
PROGESTERONE RADIOIMMUNOASSAY KIT
K791051 · JLS
Cis Radiopharmaceuticals, Inc.
Chemistry · 48d
Cleared Jul 24, 1979
BECKMAN ELECTROPHORESIS OVEN/INCUBATOR
K791077 · JRJ
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Jul 24, 1979
PLUS CHEM S.C.E. REAGENT
K791080 · CIT
Smithkline Diagnostics, Inc.
Chemistry · 42d
Cleared Jul 24, 1979
3M ORTHOPEDIC CASTING TAPE
K791094 · ITG
3M Company
Physical Medicine · 42d
Cleared Jul 24, 1979
B & L OPHTHALMIC INSTRUMENT STAND
K791104 · HMF
Bausch & Lomb, Inc.
Ophthalmic · 41d
Cleared Jul 24, 1979
B & L OPHTHALMIC CHAIR
K791105 · HMF
Bausch & Lomb, Inc.
Ophthalmic · 41d
Cleared Jul 24, 1979
SINGLE USE MONOPOLAR HAND CONTROL PENCIL
K791137 · GEI
Davol, Inc.
General & Plastic Surgery · 36d
Cleared Jul 24, 1979
5880 SERIES OF GAS CHROMATOGRAPHS
K791138 · KZQ
Hewlett-Packard Co.
Toxicology · 36d
Cleared Jul 24, 1979
PORTABLE ASPIRATOR
K791210 · JCX
Sam Say Assoc.
General & Plastic Surgery · 22d
Cleared Jul 24, 1979
BRIOX MODEL 2000-CQ QUIET COMPRESSOR
K791238 · JCX
Briox Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Jul 24, 1979
BRIOX MODEL 2000-A ASPIRATOR UNIT
K791239 · JCX
Briox Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Jul 24, 1979
BRIOX MODEL 2000-C COMPRESSOR UNIT
K791240 · JCX
Briox Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Jul 24, 1979
BRIOX MODEL 2000-CA COMPRESSOR UNIT
K791241 · JCX
Briox Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Jul 24, 1979
CONPHAR NASAL OXYGEN CANNULA-STERILE
K791247 · CAT
Conphar, Inc.
Anesthesiology · 18d
Cleared Jul 24, 1979
SECUTE ELBOW BAND
K791248 · IQI
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX WRIST BRACE
K791249 · IQI
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX KNEE BAND
K791266 · IQI
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX ANKLE BAND
K791267 · IQI
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
CONPHAR OXYGEN CATHETER-STERILE
K791273 · BZB
Conphar, Inc.
Anesthesiology · 18d
Cleared Jul 24, 1979
PERVENOUS LEAD INTRODUCER SYSTEM
K791276 · DQX
Cordis Corp.
Cardiovascular · 15d