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
130633–130656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1989
PANCREATIC A-AMYLASE PNP
K892848 · JFJ
Boehringer Mannheim Corp.
Chemistry · 93d
Cleared Jul 20, 1989
ULCERCARE
K892867 · DWL
Jobst Institute, Inc.
General Hospital · 92d
Cleared Jul 20, 1989
BIAD NUCLEAR IMAGING SYSTEM
K892875 · KPS
Trionix Research Laboratory, Inc.
Radiology · 92d
Cleared Jul 20, 1989
TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES
K892929 · CHJ
Technicon Instruments Corp.
Chemistry · 90d
Cleared Jul 20, 1989
1 VIDEO TAPE RECORDER MODEL BK-224 H
K892934 · OXO
Perkins Mfg. Co.
Radiology · 90d
Cleared Jul 20, 1989
REP(TM) CK-2 STAT KIT, CAT. NO. 3074
K893007 · CGS
Helena Laboratories
Chemistry · 87d
Cleared Jul 20, 1989
DOCUMENT(TM) URIC ACID LINEARITY TEST SET
K893139 · JIT
Casco Standards
Chemistry · 86d
Cleared Jul 20, 1989
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
K893269 · CGS
Beckman Instruments, Inc.
Chemistry · 79d
Cleared Jul 20, 1989
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
K893409 · BZT
Yellow Springs Instrument Co., Inc.
Anesthesiology · 71d
Cleared Jul 20, 1989
ALT REAGENT (PROCEDURE NUMBER 159)
K893560 · CKA
Sigma Chemical Co.
Chemistry · 72d
Cleared Jul 20, 1989
DADE LIPID-TROL
K893580 · JJY
Baxter Healthcare Corp
Chemistry · 72d
Cleared Jul 20, 1989
14 COLOR VIDEO DISPLAY 211-260-010
K893585 · LLZ
Mennen Medical, Inc.
Radiology · 72d
Cleared Jul 20, 1989
MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM
K893637 · IZL
Shimadzu Medical Systems
Radiology · 69d
Cleared Jul 20, 1989
COBAS FARA CENTRIFUGAL ANALYZER
K893641 · JJG
Roche Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Jul 20, 1989
J&S IRON SATURATING REAGENTS
K893662 · JMO
J.S. Medical Assoc.
Chemistry · 66d
Cleared Jul 20, 1989
RMS 180
K893673 · IXR
Fischer Imaging Corp.
Radiology · 66d
Cleared Jul 20, 1989
RME 325R
K893674 · IZO
Fischer Imaging Corp.
Radiology · 66d
Cleared Jul 20, 1989
MAMM-AIRE CP
K893681 · IZO
Custom Medical Products, Ltd.
Radiology · 65d
Cleared Jul 20, 1989
VISION INTEGRATED PERFORMANCE OPTION
K893689 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jul 20, 1989
SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)
K893690 · IXQ
Hofmann X-Ray of America, Inc.
Radiology · 65d
Cleared Jul 20, 1989
CENTRICON CONCENTRATOR
K893733 · JJH
Amicon, Inc.
Chemistry · 64d
Cleared Jul 20, 1989
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
K893752 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jul 20, 1989
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
K893765 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jul 20, 1989
2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR
K894053 · CCK
Fenem, Inc.
Anesthesiology · 43d