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
88921–88944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1998
INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING
K981753 · MGP
Innovative Technologies , Ltd.
General & Plastic Surgery · 43d
Cleared Jun 29, 1998
RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
K965223 · IYO
Endosonics Corp.
Radiology · 545d
Cleared Jun 29, 1998
MODEL 7410 VOYAGER
K974879 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 181d
Cleared Jun 29, 1998
SURGITRON
K980170 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 160d
Cleared Jun 29, 1998
CHROMOSCAN SCANNING SYSTEM
K980753 · GEX
Mehl/Biophile Intl., Inc.
General & Plastic Surgery · 131d
Cleared Jun 29, 1998
GENIE CUP INTEGRATED SCREENING DEVICE
K980836 · LDJ
Applied Technology Ventures, LLC
Toxicology · 117d
Cleared Jun 29, 1998
ELECSYS CEA ON THE ELECSYS 1010
K980887 · DHX
Boehringer Mannheim Corp.
Immunology · 112d
Cleared Jun 29, 1998
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
K980915 · FYD
Valleylab, Inc.
General Hospital · 110d
Cleared Jun 29, 1998
LASETTE LASER SKIN PERFORATOR
K981149 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 90d
Cleared Jun 29, 1998
OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES
K981219 · GEI
Enable Medical Corp.
General & Plastic Surgery · 87d
Cleared Jun 29, 1998
BIOSTRIDE FREE T4 EIA TEST KIT
K981243 · CEC
Biostride Diagnostics, Inc.
Chemistry · 84d
Cleared Jun 29, 1998
VANTAGE 3.0 INSYNCH
K981291 · KPS
Adac Laboratories
Radiology · 81d
Cleared Jun 29, 1998
DAUM BONE BIOPSY SET
K981320 · KNW
Daum Corp.
Gastroenterology & Urology · 80d
Cleared Jun 29, 1998
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
K981342 · GKZ
Abbott Laboratories
Hematology · 77d
Cleared Jun 29, 1998
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
K981362 · DZL
Synthes (Usa)
Dental · 75d
Cleared Jun 29, 1998
MANAN BLUNT NEEDLE
K981386 · FPA
Manan Medical Products, Inc.
General Hospital · 74d
Cleared Jun 29, 1998
QUANTECH MYOGLOBIN ASSAY
K981536 · MVE
Hellen Professional Services
Immunology · 61d
Cleared Jun 29, 1998
AST/SGOT LIQUID REAGENT - KINETIC METHOD
K981650 · CIT
Teco Diagnostics
Chemistry · 49d
Cleared Jun 29, 1998
CHOL
K981652 · CHH
Abbott Laboratories
Chemistry · 49d
Cleared Jun 29, 1998
HICHEM PHOSPHORUS REAGENT KIT
K981769 · CEO
Elan Pharma, Inc.
Chemistry · 41d
Cleared Jun 29, 1998
AST
K981843 · CIT
Abbott Laboratories
Chemistry · 34d
Cleared Jun 29, 1998
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
K981872 · DKJ
Diagnostic Chemicals , Ltd.
Toxicology · 32d
Cleared Jun 29, 1998
MODIFICATION FOR PTA BALLOON CATHETER
K981906 · LIT
Cook, Inc.
Cardiovascular · 28d
Cleared Jun 29, 1998
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
K981933 · JJW
Medical Analysis Systems, Inc.
Chemistry · 27d