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
144145–144168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1986
MMG EXTERNAL FEMALE CATHETERS
K854821 · KNX
Medical Technologies of Georgia
Gastroenterology & Urology · 142d
Cleared Apr 24, 1986
SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM
K860087 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 105d
Cleared Apr 24, 1986
BIO-PEN CALCULATOR
K860205 · LQB
Oculab, Inc.
Ophthalmic · 92d
Cleared Apr 24, 1986
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
K860335 · JLX
Diagnostic Products Corp.
Chemistry · 85d
Cleared Apr 24, 1986
SERUM CHOLINESTERASE REAGENT SET
K860350 · DLI
Sterling Diagnostics, Inc.
Chemistry · 84d
Cleared Apr 24, 1986
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
K860713 · CFJ
Catachem, Inc.
Chemistry · 57d
Cleared Apr 24, 1986
ALP (ALKALINE PHOSPHATASE) REAGENT
K860715 · CJE
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
ENZYMATIC BUN REAGENT
K860716 · CDQ
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE
K860733 · CGS
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Apr 24, 1986
BETA QUIK STICK
K860965 · JHI
Pacific Biotech, Inc.
Chemistry · 42d
Cleared Apr 24, 1986
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
K861055 · JJE
Em Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Apr 24, 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K861057 · HNR
Precision-Cosmet Co., Inc.
Ophthalmic · 36d
Cleared Apr 24, 1986
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
K861061 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 24, 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K861141 · HNR
CooperVision, Inc.
Ophthalmic · 29d
Cleared Apr 24, 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168 · LCX
Unipath , Ltd.
Chemistry · 27d
Cleared Apr 24, 1986
ULTROSPEC K KINETICS SPECTROPHOTOMETER
K861194 · JJQ
Lkb Instruments, Inc.
Chemistry · 24d
Cleared Apr 24, 1986
GLUCOSE OXIDASE PROCEDURE
K861204 · CGA
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Apr 24, 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221 · JJX
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Apr 24, 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · CFR
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 24, 1986
MMS T4 RIA KIT
K861320 · CDX
Micromedic Systems
Chemistry · 16d
Cleared Apr 24, 1986
NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY
K861328 · EAP
Belmont Equipment Corp.
Radiology · 15d
Cleared Apr 24, 1986
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
K861413 · CIG
Medical Analysis Systems, Inc.
Chemistry · 9d
Cleared Apr 23, 1986
CUDDLE HEART -AUDITORY/VIBRATION DEVICE
K845002 · FMS
International Purchasing Services
General Hospital · 483d
Cleared Apr 23, 1986
CUDDLE CARRIER - INFANT BED
K845003 · FMS
International Purchasing Services
General Hospital · 483d