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
134833–134856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 1988
PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
K882409 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 25d
Cleared Jul 01, 1988
APOLLO CONDOM
K874236 · HIS
Apollo Enterprise, Ltd. Co.
Obstetrics & Gynecology · 260d
Cleared Jul 01, 1988
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200
K874910 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 213d
Cleared Jul 01, 1988
DIGITAL NUCLEAR IMAGING SYSTEM
K875198 · IYX
Medasys, Inc.
Radiology · 197d
Cleared Jul 01, 1988
DSL SOMATOMEDIN-C (DSL #5600)
K875229 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 192d
Cleared Jul 01, 1988
BIOPSY FIXATION UNIT-TYPE UA 0997
K875357 · IYO
Bruel & Kjaer Industri A/S
Radiology · 183d
Cleared Jul 01, 1988
G-MARK
K880076 · LIC
Bainbridge Laboratories, Inc.
Microbiology · 172d
Cleared Jul 01, 1988
UNI-PORT
K880543 · KYG
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 143d
Cleared Jul 01, 1988
ESPE VARNISH
K880741 · LBH
Espe GmbH (Us)
Dental · 128d
Cleared Jul 01, 1988
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
K880750 · JGS
Nova Biomedical Corp.
Chemistry · 128d
Cleared Jul 01, 1988
SPECTROLYSE/FIBRIN
K881037 · GGP
Cytrx Biopool, Ltd.
Hematology · 112d
Cleared Jul 01, 1988
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL
K881113 · JJY
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Jul 01, 1988
SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
K881165 · IEO
Sakura Finetek U.S.A., Inc.
Pathology · 103d
Cleared Jul 01, 1988
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
K881231 · BZE
Intertech Resources, Inc.
Anesthesiology · 101d
Cleared Jul 01, 1988
NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM
K881635 · HQC
Noetix, Inc.
Ophthalmic · 78d
Cleared Jul 01, 1988
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · KYG
Alcon Laboratories
Ophthalmic · 73d
Cleared Jul 01, 1988
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K
K881795 · IZO
Shimadzu Precision Instruments, Inc.
Radiology · 65d
Cleared Jul 01, 1988
PAT PLATELET AGGREGATION TEST
K881829 · JBX
Streck Laboratories, Inc.
Hematology · 63d
Cleared Jul 01, 1988
DS-200 AND DS-400 T.E.N.S.
K881832 · GZJ
Delta Marketing, Inc.
Neurology · 63d
Cleared Jul 01, 1988
BODAI M.D.D. ADAPTOR(TM)
K881849 · BZA
B&B Medical Technologies, Inc.
Anesthesiology · 60d
Cleared Jul 01, 1988
PROSTHODENT VL
K881903 · EBF
Lee Pharmaceuticals
Dental · 56d
Cleared Jul 01, 1988
SPECIFIC CHEMISTRY ANALYZER
K882081 · JJE
The Rupp & Bowman Co.
Chemistry · 45d
Cleared Jul 01, 1988
HEMOGLOBIN SCREENING DEVICE
K882101 · KSL
Portable Medical Laboratories, Inc.
Hematology · 51d
Cleared Jul 01, 1988
SITE ULTRASONIC I/A PHACO NEEDLE
K882103 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 43d