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
78865–78888 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2001
MODIFICATION TO EXCITE
K011490 · KLE
Ivoclar North America, Inc.
Dental · 43d
Cleared Jun 27, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K011697 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Jun 27, 2001
NPAC EAR THERMOMETER MODEL TD 402
K011704 · FLL
Norm Pacific Automation Corp.
General Hospital · 26d
Cleared Jun 27, 2001
KEYST0NE MEDICAL PICC CATHETER
K011860 · FOZ
Keystone Medical
General Hospital · 13d
Cleared Jun 26, 2001
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
K003927 · BTM
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 188d
Cleared Jun 26, 2001
SYNGO MULTIMODALITY WORKSTATION
K010938 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Jun 26, 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · HOZ
Medtronic Xomed, Inc.
Ophthalmic · 68d
Cleared Jun 26, 2001
MANAN SPRITACRE SPINAL NEEDLES
K011209 · BSP
Manan Medical Products, Inc.
Anesthesiology · 68d
Cleared Jun 26, 2001
HARD RELINER
K011277 · EBI
S & C Polymer GmbH
Dental · 61d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 26, 2001
PARA 5X
K011410 · JPK
Streck Laboratories, Inc.
Hematology · 49d
Cleared Jun 26, 2001
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,...
K011542 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 39d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · MIX
Biomet, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
K011579 · JJY
Bio-Rad
Immunology · 35d
Cleared Jun 26, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH...
K011670 · DQA
Datex-Ohmeda
Anesthesiology · 27d
Cleared Jun 25, 2001
SAVINA
K003068 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 266d
Cleared Jun 25, 2001
ORACLE ORAL MASK
K003894 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 189d
Cleared Jun 25, 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · DIO
Teco Diagnostics
Toxicology · 151d
Cleared Jun 25, 2001
WAKO AUTOKIT C4
K010325 · DBI
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO AUTOKIT C3
K010326 · CZW
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
WAKO LIPID CALIBRATOR
K010334 · JIT
Wako Chemicals USA, Inc.
Immunology · 143d
Cleared Jun 25, 2001
INTER-VIAL
K010703 · LHI
Duoject Medical Systems, Inc.
General Hospital · 108d
Cleared Jun 25, 2001
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K010921 · LDJ
Advantage Diagnostics Corp.
Toxicology · 90d
Cleared Jun 25, 2001
SEP-10S PLUS, AND SP-12S PRO.
K010937 · FRN
Viltechmeda
General Hospital · 88d