FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132913–132936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1989
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
K884771 · JFP
Instrumentation Laboratory CO
Chemistry · 88d
Cleared Feb 10, 1989
AME PINSITE SHIELD(TM)
K884798 · JEC
American Medical Electronics, Inc.
Orthopedic · 86d
Cleared Feb 10, 1989
DENTAL CHAIR F1
K884830 · KLC
Fimet OY
Dental · 84d
Cleared Feb 10, 1989
STERI-OSS
K884845 · DZE
Denar Corp.
Dental · 81d
Cleared Feb 10, 1989
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO
K884864 · JJQ
The Perkin-Elmer Corp.
Toxicology · 80d
Cleared Feb 10, 1989
DADC '500' DRIVING CONTROL
K884899 · IPQ
Driving Aids Development Corp.
Physical Medicine · 74d
Cleared Feb 10, 1989
BIOTROL ALBUMIN
K885094 · CIX
Biotrol, USA, Inc.
Chemistry · 63d
Cleared Feb 10, 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134 · JGY
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Feb 10, 1989
ABSORBENT GAUZE ROLL
K885143 · EFQ
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
Cleared Feb 10, 1989
VENTREX COATED TUBE HIGH SENSITIVITY TSH
K885157 · JLW
Ventrex Laboratories, Inc.
Chemistry · 59d
Cleared Feb 10, 1989
MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD
K885240 · DTB
Tpl-Cordis, Inc.
Cardiovascular · 51d
Cleared Feb 10, 1989
HDL CHOLESTEROL TEST
K885265 · LBR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Feb 10, 1989
DENTAL SYRINGE APPLICATION TIP
K890064 · EKJ
Centrix, Inc.
Dental · 32d
Cleared Feb 10, 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · CGJ
Abbott Laboratories
Chemistry · 28d
Cleared Feb 10, 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Feb 10, 1989
DETECTABUSE DRUG CONTROLS
K890406 · DIF
Eastern Laboratories, Ltd.
Toxicology · 17d
Cleared Feb 10, 1989
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR
K890451 · DLJ
Syva Co.
Toxicology · 11d
Cleared Feb 10, 1989
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR
K890452 · DLJ
Syva Co.
Toxicology · 11d
Cleared Feb 10, 1989
ABC, ABC-1X, ABC(TM)
K890482 · KIT
Cell Ent., Inc.
Pathology · 10d
Cleared Feb 10, 1989
SECOND ASSISTANT
K890501 · FWZ
3M Company
General & Plastic Surgery · 9d
Cleared Feb 10, 1989
SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE
K890503 · GKB
Gespac, Inc.
Hematology · 9d
Cleared Feb 10, 1989
SUPERCAIR
K890523 · INX
Ssi Medical Services, Inc.
Physical Medicine · 8d
Cleared Feb 09, 1989
ANESTY 10
K880744 · GZJ
Nihon Medix Co., Ltd.
Neurology · 351d
Cleared Feb 09, 1989
INTERLABIAL PAD
K881384 · HEB
Xtramedics, Inc.
Obstetrics & Gynecology · 314d