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
149689–149712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1985
ACE INTRAMEDULLARY ROD FOR SMALL BONES
K850142 · HSB
Buckman Co., Inc.
Orthopedic · 24d
Cleared Feb 07, 1985
COPAL DIGITAL THERMOMETER UF-12
K850195 · FLL
Takeda Medical, Inc.
General Hospital · 20d
Cleared Feb 07, 1985
COPAL DIGITAL THERMOMETER UF-22B
K850196 · FLL
Takeda Medical, Inc.
General Hospital · 20d
Cleared Feb 07, 1985
ISOCONTROL SERUM LD-
K850211 · JJT
Sclavo, Inc.
Chemistry · 23d
Cleared Feb 07, 1985
ISOENZYME TEST CK-MB
K850212 · CGS
Sclavo, Inc.
Chemistry · 23d
Cleared Feb 07, 1985
BREWER HEAVE-DUTY I.V. STAND W/FOOT OPERATED PNUEM
K850245 · FOX
E.F. Brewer Co.
General Hospital · 16d
Cleared Feb 07, 1985
BCS POTASSIUM TURBIDIMETRIC TEST
K850258 · CEJ
Bioclinical Systems, Inc.
Chemistry · 16d
Cleared Feb 06, 1985
SURGICAL MODULE 7000 ECG
K840869 · DPS
Marquette Electronics, Inc.
Cardiovascular · 345d
Cleared Feb 06, 1985
ANTERIOR CRUCIATE LIGAMENT GRASPER
K841241 · HRX
Surgical Products Corp.
Orthopedic · 320d
Cleared Feb 06, 1985
MICRO ORGANISM GROWTH SYS-M1000
K843000 · LIO
Hml Inc/Biotechnology Transfer
Microbiology · 191d
Cleared Feb 06, 1985
MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL
K844115 · GZB
Medtronic Vascular
Neurology · 106d
Cleared Feb 06, 1985
ARGON/KRYPTON LASER SYSTEM 8500
K844209 · HQB
Cooper Lasersonics, Inc.
Ophthalmic · 98d
Cleared Feb 06, 1985
SPECIMEN COLLECTION & TRANSPORT SYSTEM
K844475 · FMF
Portable Medical Laboratories, Inc.
General Hospital · 79d
Cleared Feb 06, 1985
IMAGEN CHLAMYDIA TEST
K844683 · IWP
Boots-Celltech Diagnostics, Inc.
Microbiology · 68d
Cleared Feb 06, 1985
PARAGON TRICHECK ELECTROPHORESIS CONTROL
K844996 · JJY
Beckman Instruments, Inc.
Chemistry · 42d
Cleared Feb 06, 1985
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
K850056 · JLS
Leeco Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 06, 1985
CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAY
K850140
Corning Medical & Scientific
Chemistry · 23d
Cleared Feb 06, 1985
ACTIVE CORTISOL DSL 2000-SP
K850141 · CGR
Diagnostic Systems Laboratories, Inc.
Chemistry · 23d
Cleared Feb 06, 1985
TDX ETHOSUXIMIDE
K850174 · DLF
Abbott Laboratories
Toxicology · 20d
Cleared Feb 06, 1985
GELMAN TRIPHOR CONTROL
K850202 · JJY
Gelman Sciences, Inc.
Chemistry · 19d
Cleared Feb 06, 1985
CALCIUM
K850281 · CIC
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Feb 04, 1985
MINUTEMAN CO2 MICROSURGICAL LASER GYN
K843515 · HHR
American Surgical Laser, Inc.
Obstetrics & Gynecology · 152d
Cleared Feb 04, 1985
CANMED 103
K844098 · GXY
Medtronic Vascular
Neurology · 104d
Cleared Feb 04, 1985
PALMER OBSTETIC BRACE
K844183 · KNC
Mic Medical Corp.
Obstetrics & Gynecology · 101d