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
137497–137520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1987
PARAMAX AMYLASE REAGENT
K873520 · CJA
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
PARAMAX CREATININE REAGENT
K873531 · CGX
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
PARAMAX UREA NITROGEN REAGENT
K873532 · CDQ
Baxter Healthcare Corp
Chemistry · 83d
Cleared Nov 23, 1987
OVUGEN SURETEST
K873534 · CEP
Biogenex Laboratories
Chemistry · 83d
Cleared Nov 23, 1987
APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY
K873563 · JOL
Aplicare, Inc.
General Hospital · 82d
Cleared Nov 23, 1987
IMSI, VITAL CALL
K873612 · IQA
Intl. Management Services, Inc.
Physical Medicine · 76d
Cleared Nov 23, 1987
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680 · DSI
Oxford Medilog, Inc.
Cardiovascular · 70d
Cleared Nov 23, 1987
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504
K873788 · JHI
Pacific Biotech, Inc.
Chemistry · 67d
Cleared Nov 23, 1987
MODEL 500E INFANT MONITORING SYSTEM
K873791 · BZQ
Ge Medical Systems Information...
Anesthesiology · 67d
Cleared Nov 23, 1987
REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
K873832 · KRZ
In Vitro Diagnostics, Inc.
Hematology · 63d
Cleared Nov 23, 1987
INFUSION MANIFOLD
K873852 · FPK
Advanced Surgical Products, Inc.
General Hospital · 62d
Cleared Nov 23, 1987
MODIFIED PARAMAX GLUCOSE REAGENT
K873936 · CFR
Baxter Healthcare Corp
Chemistry · 59d
Cleared Nov 23, 1987
A-GENT LIQUID AMYLASE
K873944 · JFJ
Abbott Laboratories
Chemistry · 56d
Cleared Nov 23, 1987
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY
K873945 · CDP
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Nov 23, 1987
DISPOSABLE BIPOLAR FORCEPS
K873978 · GEN
E.M. Adams
General & Plastic Surgery · 54d
Cleared Nov 23, 1987
ACU-MICRO-NEEDLE
K874024 · FMI
Acuderm, Inc.
General Hospital · 52d
Cleared Nov 23, 1987
MAMEX DC S SL10/MG14
K874040 · IZH
Orion Corp.
Radiology · 49d
Cleared Nov 23, 1987
INFLATABLE FOOT & ANKLE SPLINT
K874050 · FZF
Vinyl Technology, Inc.
General & Plastic Surgery · 49d
Cleared Nov 23, 1987
INFLATABLE FULL LEG SPLINT
K874051 · FZF
Vinyl Technology, Inc.
General & Plastic Surgery · 49d
Cleared Nov 23, 1987
INFLATABLE HALF LEG SPLINT
K874052 · FZF
Vinyl Technology, Inc.
General & Plastic Surgery · 49d
Cleared Nov 23, 1987
INFLATABLE FULL ARM SPLINT
K874053 · FZF
Vinyl Technology, Inc.
General & Plastic Surgery · 49d
Cleared Nov 23, 1987
360D DC DEFIBRILLATOR
K874091 · LDD
Medac, Inc.
Cardiovascular · 47d
Cleared Nov 23, 1987
TITAN GEL REP LDH-12 HV
K874143 · CFE
Helena Laboratories
Chemistry · 41d
Cleared Nov 23, 1987
TITAN GEL REP CPK-6 HV
K874144 · JHX
Helena Laboratories
Chemistry · 41d