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
140713–140736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1987
ENDOMYOCARDIAL BIOPSY DEVICE
K870186 · DWZ
Mansfield Scientific, Inc.
Cardiovascular · 35d
Cleared Feb 20, 1987
UNITED SURGICAL CORP. DIATHERMIC PLUS
K870194 · HQR
United Surgical Corp.
Ophthalmic · 31d
Cleared Feb 20, 1987
UNITED SURGICAL CORP. CRYOPTIC PLUS
K870195 · HPS
United Surgical Corp.
Ophthalmic · 31d
Cleared Feb 20, 1987
CRYSTAL MASK
K870206 · BYG
Brunswick Mfg. Co., Inc.
Anesthesiology · 31d
Cleared Feb 20, 1987
ARTHROSCOPIC SHOULDER HOLDER
K870212 · HST
Dyonics, Inc.
Neurology · 31d
Cleared Feb 20, 1987
COMPRESS AND SKULLCAP, HEAD DRESSING
K870240 · EXR
Fraass Survival Systems, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 20, 1987
DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET
K870252 · JJY
Casco Standards
Chemistry · 30d
Cleared Feb 20, 1987
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K870265 · KYB
CooperVision, Inc.
Ophthalmic · 28d
Cleared Feb 20, 1987
CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695
K870278 · LPN
Ryder Intl. Corp.
Ophthalmic · 24d
Cleared Feb 20, 1987
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71
K870336 · DKJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Feb 20, 1987
LOOK IRRIGATING/ASPIRATING CANNULAS
K870436 · HMX
Look, Inc.
Ophthalmic · 17d
Cleared Feb 20, 1987
LOOK CAPSULE POLISHERS/SCRAPERS
K870437 · HNZ
Look, Inc.
Ophthalmic · 17d
Cleared Feb 20, 1987
LOOK IRRIGATING CANNULAS
K870438 · HMX
Look, Inc.
Ophthalmic · 17d
Cleared Feb 20, 1987
LOOK IRRIGATING CYSTOTOMES
K870439 · HNY
Look, Inc.
Ophthalmic · 17d
Cleared Feb 20, 1987
LOOK LENS LOOPS
K870440 · HNQ
Look, Inc.
Ophthalmic · 17d
Cleared Feb 20, 1987
LOOK CORTEX EXTRACTORS
K870441 · HMX
Look, Inc.
Ophthalmic · 17d
Cleared Feb 19, 1987
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · DXG
Nihon Kohden America, Inc.
Cardiovascular · 478d
Cleared Feb 19, 1987
INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER
K855247 · ITX
Codman & Shurtleff, Inc.
Radiology · 423d
Cleared Feb 19, 1987
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
K862261 · DXG
Kontron Instruments, Inc.
Cardiovascular · 251d
Cleared Feb 19, 1987
AUSTENAL ACUSOFT SOFT LINER
K862557 · EBI
Austenal Dental, Inc.
Dental · 231d
Cleared Feb 19, 1987
BIOMA 2000
K862808 · DXG
E.B.S., Inc.
Cardiovascular · 211d
Cleared Feb 19, 1987
RMI FEMORAL VENOUS DRAINAGE CANNULA
K863740 · DWF
Research Medical, Inc.
Cardiovascular · 149d
Cleared Feb 19, 1987
MODIFIED STBP-680
K863891 · DXN
Quinton, Inc.
Cardiovascular · 136d
Cleared Feb 19, 1987
AMPLATZ MOVEABLE CORE GUIDEWIRE
K864058 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 122d