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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96433–96456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1996
PROSTYLE COMPACT
K961420 · EIA
Planmeca Oy
Dental · 151d
Cleared Sep 10, 1996
QUATROLOC FEMORAL COMPONENT & HEAD
K961625 · LPH
Whiteside Biomechanics, Inc.
Orthopedic · 137d
Cleared Sep 10, 1996
PREPOWDER VINYL PATIENT EXAMINATION GLOVES
K962026 · LYZ
Hong Huang Tang Industrial Co., Ltd.
General Hospital · 110d
Cleared Sep 10, 1996
0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES...
K962266 · DQX
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Sep 10, 1996
PERFECTA PS REVISION STEM
K962267 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 89d
Cleared Sep 10, 1996
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
K962342 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 84d
Cleared Sep 10, 1996
TAP ANTI-SNORING DEVICE
K962516 · LRK
Nellcor Puritan Bennett, Inc.
Dental · 75d
Cleared Sep 10, 1996
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
K962664 · GKP
Medical Laboratory Automation...
Hematology · 63d
Cleared Sep 10, 1996
YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
K962712 · HEB
Talbot S. Lindstrom
Obstetrics & Gynecology · 60d
Cleared Sep 10, 1996
DSL DHEA-S-7
K962895 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 47d
Cleared Sep 10, 1996
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123,...
K963047 · ESD
Fenwick Hearing Instruments
Ear, Nose, Throat · 43d
Cleared Sep 10, 1996
STERI-OSS TEMPORARY IMPLANT CEMENT
K963078 · EMA
Steri-Oss, Inc.
Dental · 33d
Cleared Sep 10, 1996
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158 · LFM
Abbott Laboratories
Toxicology · 46d
Cleared Sep 10, 1996
ELECSYS CALCHECK T UPDATE
K963181 · JJX
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Sep 10, 1996
CEDIA ANTIBIOTIC TDM MULTI-CALS
K963191 · DKB
Boehringer Mannheim Corp.
Toxicology · 26d
Cleared Sep 09, 1996
PERSONAL TELEMEDICINE SYSTEM
K952882 · DXN
American Telecare, Inc.
Cardiovascular · 444d
Cleared Sep 09, 1996
CAMVISION 1000
K953974 · JAA
Medivision Medical Imaging, Ltd.
Radiology · 383d
Cleared Sep 09, 1996
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
K955770 · JQB
Abaxis, Inc.
Chemistry · 263d
Cleared Sep 09, 1996
PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
K960715 · MJN
Ideas For Medicine, Inc.
Cardiovascular · 201d
Cleared Sep 09, 1996
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
K961023 · LMD
Accuimage, Inc.
Radiology · 179d
Cleared Sep 09, 1996
DSL ACTIVE FSH IRMA
K962118 · CGJ
Diagnostic Systems Laboratories, Inc.
Chemistry · 101d
Cleared Sep 09, 1996
REAL-TIME VIDEO CONTRAST ENHANCER
K962260 · LLZ
Digivision, Inc.
Radiology · 89d
Cleared Sep 09, 1996
AIR MAX EXTERNAL NASAL DILATOR STRIP
K962400 · LWF
American White Cross, Inc.
Ear, Nose, Throat · 80d
Cleared Sep 09, 1996
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
K962469 · MID
American Laboratory Products Co., Ltd.
Immunology · 76d